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2. Staging laparoscopy in gastric cancer patients: From a Dutch nationwide Delphi consensus towards a standardized protocol

Author

van Berge Henegouwen, M.I., Gisbertz, S.S., Eshuis, W.J., Daams, F., Borstlap, W.A., Luyer, M.D.P., Simkens, G.A., Nieuwenhuizen, G.A.P., van der Sluis, P.C., Lagarde, S.M., Noordman, B.J., Heisterkamp, J., Matthijsen, R.A., Matthée, E.P.C., Wassenaar, E.B., Pierik, E.G.J.M., Hartgrink, H.H., de Steur, W.O., Hutteman, M., van der Harst, E., Pierie, J.E.N., Emous, M., Kelder, W., Hartemink, K.J., Veenhof, A.A.F.A., Hugen, N., Klarenbeek, B.R., van Esser, S., Bilgen, E.J. Spillenaar, Witteman, B.P.L., van Etten, B., Dijkstra, F.A., Haveman, J.W., van der Bilt, A., van Hillegersberg, R., van den Berg, J.W., Brenkman, H.J.F., Kouwenhoven, E.A., van Det, M.J., Stoot, J.H.M.B., Belgers, E.H.J., Sosef, M.N., van der Sluis, Karen, Guchelaar, Niels A.D., Triemstra, Lianne, Mathijssen, Ron H.J., Ruurda, Jelle P., Wijnhoven, Bas P.L., and van Sandick, Johanna W.

Published
2024
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5. The value of post-operative chemotherapy after chemoradiotherapy in patients with high-risk locally advanced rectal cancer—results from the RAPIDO trial

Author

Dijkstra, E.A., Zwart, W.H., Nilsson, P.J., Putter, H., Roodvoets, A.G.H., Meershoek-Klein Kranenbarg, E., Frödin, J.E., Nygren, P., Østergaard, L., Kersten, C., Verbiené, I., Cervantes, A., Hendriks, M.P., Capdevila, J., Edhemovic, I., van de Velde, C.J.H., Marijnen, C.A.M., van Etten, B., Hospers, G.A.P., and Glimelius, B.

Published
2023
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6. Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer (OMEGA trial): study protocol for a randomized controlled trial.

Author

Keywani, K., Eshuis, W. J., Borgstein, A. B. J., van Det, M. J., van Duijvendijk, P., van Etten, B., Grimminger, P. P., Heisterkamp, J., Lagarde, S. M., Luyer, M. D. P., Markar, S. R., Meijer, S. L., Pierie, J. P. E. N., Roviello, F., Ruurda, J. P., van Sandick, J. W., Sosef, M., Witteman, B. P. L., de Steur, W. O., and Lissenberg-Witte, B. I.

Subjects
STOMACH cancer, OVERALL survival, BOWEL obstructions, RANDOMIZED controlled trials, PROGRESSION-free survival
Abstract

Background: Potentially curative therapy for locally advanced gastric cancer consists of gastrectomy, usually in combination with perioperative chemotherapy. An oncological resection includes a radical (R0) gastrectomy and modified D2 lymphadenectomy; generally, a total omentectomy is also performed, to ensure the removal of possible microscopic disease. However, the omentum functions as a regulator of regional immune responses to prevent infections and prevents adhesions which could lead to bowel obstructions. Evidence supporting a survival benefit of routine complete omentectomy during gastrectomy is lacking. Methods: OMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Eligible patients are operable (ASA < 4) and have resectable (≦ cT4aN3bM0) primary gastric cancer. Patients will be 1:1 randomized between (sub)total gastrectomy with omentum preservation distal of the gastroepiploic vessels versus complete omentectomy. For a power of 80%, the target sample size is 654 patients. The primary objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of 3-year overall survival. Secondary endpoints include intra- and postoperative outcomes, such as blood loss, operative time, hospital stay, readmission rate, quality of life, disease-free survival, and cost-effectiveness. Discussion: The OMEGA trial investigates if omentum preservation during gastrectomy for gastric cancer is non-inferior to complete omentectomy in terms of 3-year overall survival, with non-inferiority being determined based on results from both the intention-to-treat and the per-protocol analyses. The OMEGA trial will elucidate whether routine complete omentectomy could be omitted, potentially reducing overtreatment. Trial registration: ClinicalTrials.gov NCT05180864. Registered on 6th January 2022. [ABSTRACT FROM AUTHOR]

Published
2024
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8. Staging laparoscopy in gastric cancer patients:From a Dutch nationwide Delphi consensus towards a standardized protocol

Author

van der Sluis, Karen, Guchelaar, Niels A.D., Triemstra, Lianne, Mathijssen, Ron H.J., Ruurda, Jelle P., Wijnhoven, Bas P.L., van Sandick, Johanna W., Daams, F., van der Sluis, P. C., Lagarde, S. M., Noordman, B. J., Heisterkamp, J., Matthée, E. P.C., Wassenaar, E. B., Pierik, E. G.J.M., van der Harst, E., Veenhof, A. A.F.A., van Etten, B., van Hillegersberg, R., van den Berg, J. W., Brenkman, H. J.F., Kouwenhoven, E. A., van der Sluis, Karen, Guchelaar, Niels A.D., Triemstra, Lianne, Mathijssen, Ron H.J., Ruurda, Jelle P., Wijnhoven, Bas P.L., van Sandick, Johanna W., Daams, F., van der Sluis, P. C., Lagarde, S. M., Noordman, B. J., Heisterkamp, J., Matthée, E. P.C., Wassenaar, E. B., Pierik, E. G.J.M., van der Harst, E., Veenhof, A. A.F.A., van Etten, B., van Hillegersberg, R., van den Berg, J. W., Brenkman, H. J.F., and Kouwenhoven, E. A.

Abstract

Background: Staging laparoscopy is a common diagnostic tool in gastric cancer, but its performance varies widely. The aim of this study was to gain Dutch nationwide consensus regarding the indications for and execution of staging laparoscopy in patients with gastric cancer. Methods: All surgeons in the Netherlands specialized in gastric cancer surgery (n = 52) were asked to participate in a Delphi consensus study. The study involved an initial questionnaire with a 3-point Likert scale, an online consensus meeting, and a second questionnaire using a 2-point Likert scale (agree/disagree). Consensus was defined as 70% or more agreement among participants. Results: In total, 45 experts completed both questionnaires (87% response rate). Consensus was reached on the indication to perform staging laparoscopy in cT3-4 or cN + or diffuse-type gastric cancer, including Siewert type III oesophagogastric junctional cancer. The experts agreed that if preoperative scans suggest infiltration of surrounding organs (cT4), the tumour's resectability should explicitly be investigated. Consensus was also reached for a systematic peritoneal cavity inspection according to Sugarbaker's Peritoneal Cancer Index (PCI) score. All regions should be inspected routinely, although the omental bursa may be inspected on indication. Aspiration of ascites or peritoneal washing should be performed for cytology. The experts agreed that restaging laparoscopy should be performed before resection in case of progressive disease on preoperative imaging. Without progression, global inspection was considered sufficient. Conclusions: The results of this Dutch nationwide Delphi consensus study exposed the variability of performing staging laparoscopy in patients with gastric cancer and provided the concept for a standardized protocol.

Published
2024

9. Pelvic Floor Rehabilitation After Rectal Cancer Surgery: A Multicenter Randomized Clinical Trial (FORCE Trial)

Author

van der Heijden, J. A. G., Kalkdijk-Dijkstra, A. J., Pierie, J. P. E. N., van Westreenen, H. L., Broens, P. M. A., Klarenbeek, B. R., de Wilt, JHW, Stommel, MWJ, Bremers, AJA, Rosman, C, de Reuver, PR, Bouwense, SAW, van der Kolk, BM, Garms, LM, Meerten-van den Belt, K, Olde Hartman-Hofste, MRM, Peters, JWM, Olsder, L, Huizing, I, Trzpis, M, Furnee, EJB, Havenga, K, Hemmer, PHJ, van Etten, B, Koop, A, van der Heide, L, Kamphuis, D, Koopal, SA, Hoff, C, Eker, H, Junte, HHM, Schoenaker, IJH, Quaedackers, S, Bos, MJ, Gardien, H, van Sprundel, TC, de Vries, PD, Ashruf, JF, Geurts, L, Nielen, I, Pfeil, J, van Ark, M, Polle, SW, Hansson, B, Polat, F, de Vries, H, ten Berge-Groen, E, Talsma, AK, Bosker, R, Veurink, E, Papa, M, Maaskant-Braat, AJG, van den Broek, FJC, Leclercq, WKG, Slooter, GD, Caers, F, Boeijen, M, van den Broek, R, van Schaik, K, Wasowicz-Kemps, DK, Langenhoff, BS, van den Bogaard, MJ, van der Sluis, J, Arisz, D, Bruinsma, S, Hess, DA, Mulder, EJ, Wiering, B, Kok, S, Woltering, J, Raap-van Sleuwen, B, Schoonderwoerd, L, Hendriks, D, van den Elzen, N, van de Laak, I, Valk, M, van der Meij, W, van Wely, BJ, van Hoogstraten, MJ, van der Sluis, M, Paulusma, I, Mollers, MJW, Looijen, R, van der Mijle, HCJ, Pereboom, ITA, Tijink-Callenbach, PMC, Schasfoort, RA, van der Hagen, SJ, van de Meer, W, Lubberink, M, van Haskera, M, Wit, F, Jeeninga, M, ten Hoeve, R, Slootmans, FCW, Inberg, B, de Nes, L, Toonen, D, Wilmsen, MA, Buyne, O, Ferenschild, F, de Vries, M., Adamse, C, Hettema-Beets, BL, Goudswaard, MK, van der Velde, M, Elving, DW, Arends-Smit, RE, Buiter, JR, van der itte-van Aerle, I, Jansma, K, Kooistra, L, Lohof-Venema, S, Kruijer, MR, Dijkstra, G, van der erf-Elling, MA, Kats-de Boer, V, Rinsema, AM, Haarlemmer-Lutjeboer, M, van der Vegt, A, Berends-Pors, SMH, Ponstein, AJ, Klaassen, G, Nieuwint, AM, Veninga-Jansen, M, Dries-Jansen, V, Arends, FJ, Stellingwerf-Goinga, NE, Overmars, NG, van Asma, H, Beverdam, K, Ploumen, MJAC, Tijhuis, M, Visser Duiven, AH, Former, M, Smans-Kaal, MAL, Vorsterman van Oijen-Linthorst, CMJ, Hovels-Kamp, NN, Vorsteveld, LR, Vermeulen, N, Alkemade-van Veghel, A, Steentjes, LJ, Cornelisse-Theunissen, HGM, Strijbosch, J, Sniekers, S, Oerlemans-van Oijen, JMA, Hoefnagels, HMJ, Sniekers, CJDA, Biemans, S, Bomert-Wendt, Y, van Gaal, HGM, Smulders, AHCW, Adams, W, Kappen, JM, Vermeltfoort-Jansen, AM, Zegger, MGC, Vrielink, C, Slotman, HM, Claessens, NJH, Manders-de Groot, AWM, van Beuzekom-van der Vorst, CTPG, Swinkels-Nijssen, MWC, van Oeveren, P, van Leeuwen-Nellestijn, JPF, Bleijenberg, M, Valenteyn-Hidden, JJF, van Rutten-de Groot, MG, van den van der Heijden, M, Nieuwenhuizen, Boorsma, PG, Broodman, N, Elling, ME, Bokkers-Engelen, E, Hilhorst-Droppers, GH, Mein, HJC, and Gielen, M

Published
2022
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18. The value of post-operative chemotherapy after chemoradiotherapy in patients with high-risk locally advanced rectal cancerdresults from the RAPIDO trial

Author

Dijkstra, E. A., Zwart, W. H., Nilsson, P. J., Putter, H., Roodvoets, A. G. H., Kranenbarg, E. Meershoek-Klein, Froedin, J. E., Nygren, Peter, ostergaard, L., Kersten, C., Verbiene, I., Cervantes, A., Hendriks, M. P., Capdevila, J., Edhemovic, I., van de Velde, C. J. H., Marijnen, C. A. M., van Etten, B., Hospers, G. A. P., Glimelius, Bengt, Dijkstra, E. A., Zwart, W. H., Nilsson, P. J., Putter, H., Roodvoets, A. G. H., Kranenbarg, E. Meershoek-Klein, Froedin, J. E., Nygren, Peter, ostergaard, L., Kersten, C., Verbiene, I., Cervantes, A., Hendriks, M. P., Capdevila, J., Edhemovic, I., van de Velde, C. J. H., Marijnen, C. A. M., van Etten, B., Hospers, G. A. P., and Glimelius, Bengt

Abstract

Background: Pre-operative chemoradiotherapy (CRT) rather than radiotherapy (RT) has resulted in fewer locoregional recurrences (LRRs), but no decrease in distant metastasis (DM) rate for patients with locally advanced rectal cancer (LARC). In many countries, patients receive post-operative chemotherapy (pCT) to improve oncological outcomes. We investigated the value of pCT after pre-operative CRT in the RAPIDO trial. Patients and methods: Patients were randomised between experimental (short-course RT, chemotherapy and surgery) and standard-of-care treatment (CRT, surgery and pCT depending on hospital policy). In this substudy, we compared curatively resected patients from the standard-of-care group who received pCT (pCT+ group) with those who did not (pCT- group). Subsequently, patients from the pCT+ group who received at least 75% of the prescribed chemotherapy cycles (pCT >75% group) were compared with patients who did not receive pCT (pCT-/- group). By propensity score stratification (PSS), we adjusted for the following unbalanced confounders: age, clinical extramural vascular invasion, distance to the anal verge, ypT stage, ypN stage, residual tumour, serious adverse event (SAE) and/or readmission within 6 weeks after surgery and SAE related to pre-operative CRT. Cumulative probability of disease-free survival (DFS), DM, LRR and overall survival (OS) was analysed by Cox regression. Results: In total, 396/452 patients had a curative resection. The number of patients in the pCT+, pCT >75%, pCT- and pCT-/- groups was 184, 112, 154 and 149, respectively. The PSS-adjusted analyses for all endpoints demonstrated hazard ratios between approximately 0.7 and 0.8 (pCT+ versus pCT-), and 0.5 and 0.8 (pCT >75% versus pCT-/-). However, all 95% confidence intervals included 1. Conclusions: These data suggest a benefit of pCT after pre-operative CRT for patients with high-risk LARC, with approximately 20%-25% improvement in DFS and OS and 20%-25% risk reductions in DM

Published
2023
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19. Authors' reply-A sensitivity analysis of the RAPIDO clinical trial

Author

Dijkstra, E. A., Zwart, W. H., Putter, H., Marijnen, C. A. M., Nilsson, P. J., van de Velde, C. J. H., van Etten, B., Hospers, G. A. P., Glimelius, Bengt, Dijkstra, E. A., Zwart, W. H., Putter, H., Marijnen, C. A. M., Nilsson, P. J., van de Velde, C. J. H., van Etten, B., Hospers, G. A. P., and Glimelius, Bengt

Published
2023
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20. Evaluation of PET and laparoscopy in STagIng advanced gastric cancer: a multicenter prospective study (PLASTIC-study)

Author

Brenkman, H. J. F., Gertsen, E. C., Vegt, E., van Hillegersberg, R., van Berge Henegouwen, M. I., Gisbertz, S. S., Luyer, M. D. P., Nieuwenhuijzen, G. A. P., van Lanschot, J. J. B., Lagarde, S. M., de Steur, W. O., Hartgrink, H. H., Stoot, J. H. M. B., Hulsewe, K. W. E., Spillenaar Bilgen, E. J., van Det, M. J., Kouwenhoven, E. A., van der Peet, D. L., Daams, F., van Sandick, J. W., van Grieken, N. C. T., Heisterkamp, J., van Etten, B., Haveman, J. W., Pierie, J. P., Jonker, F., Thijssen, A. Y., Belt, E. J. T., van Duijvendijk, P., Wassenaar, E., van Laarhoven, H. W. M., Wessels, F. J., Haj Mohammad, N., van Stel, H. F., Frederix, G. W. J., Siersema, P. D., Ruurda, J. P., and on behalf of the PLASTIC Study Group

Published
2018
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23. Quality of life, functional outcome and late toxicity in patients treated within the RAPIDO trial

Author

Dijkstra, E., Hospers, G., van de Velde, C., Fleer, J., Bahadoer, R., Guren, M., Tjalma, J., Putter, H., Kranenbarg, E. Meershoek-Klein, Roodvoets, A., ten Tije, A., Capdevila, J., Hendriks, M., Cervantes, A., Nilsson, P., Glimelius, B., van Etten, B., Marijnen, C., Guided Treatment in Optimal Selected Cancer Patients (GUTS), Lifelong Learning, Education & Assessment Research Network (LEARN), and Health Psychology Research (HPR)

Published
2021

24. OC-0337 Quality of life, functional outcome and late toxicity in patients treated within the RAPIDO trial

Author

Dijkstra, E., primary, Hospers, G., additional, van de Velde, C., additional, Fleer, J., additional, Bahadoer, R., additional, Guren, M., additional, Tjalma, J., additional, Putter, H., additional, Meershoek-Klein Kranenbarg, E., additional, Roodvoets, A., additional, ten Tije, A., additional, Capdevila, J., additional, Hendriks, M., additional, Cervantes, A., additional, Nilsson, P., additional, Glimelius, B., additional, van Etten, B., additional, and Marijnen, C., additional

Published
2021
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26. Fluorescence Molecular Endoscopy (FME) Using Bevacizumab-800CW to Evaluate Response to Neoadjuvant Chemoradiotherapy in Esophageal Cancer: Preliminary Results

Author

Schmidt, I, additional, Zhao, X, additional, Kats-Ugurlu, G, additional, van der Waaij, A.M, additional, Gabriels, RY, additional, van der Laan, JJ, additional, Dijkstra, FA, additional, Haveman, JW, additional, van Etten, B, additional, Robinson, DJ, additional, and Nagengast, WB, additional

Published
2021
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27. Compliance and tolerability of short-course radiotherapy followed by preoperative chemotherapy and surgery for high-risk rectal cancer - Results of the international randomized RAPIDO-trial (vol 147, pg 75, 2020)

Author

van der Valk M, Marijnen C, van Etten B, Dijkstra E, Hilling D, Kranenbarg E, Putter H, Roodvoets A, Bahadoer R, Fokstuen T, ten Tije A, Capdevila J, Hendriks M, Edhemovic I, Cervantes A, de Groot D, Nilsson P, Glimelius B, van de Velde C, Hospers G, and Collaborative Investigators

Published
2020

30. Nationwide Outcome of Gastrectomy with En-Bloc Partial Pancreatectomy for Gastric Cancer

Author

van der Werf, L.R., primary, Eshuis, W.J., additional, Draaisma, W.A., additional, van Etten, B., additional, Gisbertz, S.S., additional, van der Harst, E., additional, Liem, M.S.L., additional, Lemmens, V.E.P.P., additional, Wijnhoven, B.P.L., additional, Besselink, M.G., additional, van Berge Henegouwen, M.I., additional, van Hillegersberg, R., additional, van Eijden, Y., additional, van Esser, S., additional, Hartgrink, H.H., additional, de Jong, G., additional, Karsten, T.M., additional, Kouwenhoven, E.A., additional, Lagarde, S.M., additional, Nieuwenhuijzen, G.A.P., additional, van der Peet, D.L., additional, van Sandick, J.W., additional, Talsma, A.K., additional, and Tetteroo, G.W.M., additional

Published
2019
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34. Preoperative image-guided identification of response to neoadjuvant chemoradiotherapy in esophageal cancer (PRIDE): A multicenter observational study

Author

Borggreve, A. S., Mook, S., Verheij, M., Mul, V. E.M., Bergman, J. J., Bartels-Rutten, A., Ter Beek, L. C., Beets-Tan, R. G.H., Bennink, R. J., Van Berge Henegouwen, M. I., Brosens, L. A.A., Defize, I. L., Van Dieren, J. M., Dijkstra, H., Van Hillegersberg, R., Hulshof, M. C., Van Laarhoven, H. W.M., Lam, M. G.E.H., Van Lier, A. L.H.M.W., Muijs, C. T., Nagengast, W. B., Nederveen, A. J., Noordzij, W., Plukker, J. T.M., Van Rossum, P. S.N., Ruurda, J. P., Van Sandick, J. W., Weusten, B. L.A.M., Voncken, F. E.M., Yakar, D., Meijer, G. J., Aleman, B. M.P., Borra, R. J.H., Van Etten, B., Gisbertz, S. S., Goense, L., Haj Mohammad, N., Hartemink, K. J., Kappert, P., Kats-Ugurlu, G., Kodach, L. L., Korteweg, T., Krishnadath, K. K., Langendijk, J. A., De Leng, W. W.J., Meijer, S. L., Potze, J. H., Stoker, J., Vegt, E., Verkooijen, H. M., Vollenbrock, S. E., Wessels, F., Guided Treatment in Optimal Selected Cancer Patients (GUTS), Damage and Repair in Cancer Development and Cancer Treatment (DARE), ​Basic and Translational Research and Imaging Methodology Development in Groningen (BRIDGE), Gastroenterology and Hepatology, AGEM - Re-generation and cancer of the digestive system, Nuclear Medicine, Radiology and Nuclear Medicine, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Surgery, CCA - Imaging and biomarkers, Radiotherapy, Oncology, ACS - Diabetes & metabolism, AMS - Restoration & Development, ANS - Brain Imaging, Pathology, and AGEM - Digestive immunity

Subjects
Cancer Research, Esophageal Neoplasms, PREDICTION, SURGERY, medicine.medical_treatment, Esophageal cancer, FREE DNA, Study Protocol, 0302 clinical medicine, Positron Emission Tomography Computed Tomography, Pathologic complete response, PATHOLOGICAL COMPLETE RESPONSE, FDG-PET, medicine.diagnostic_test, Image-guided, Chemoradiotherapy, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Primary tumor, Neoadjuvant Therapy, Neoadjuvant chemoradiotherapy, medicine.anatomical_structure, Fine-needle aspiration, Treatment Outcome, Oncology, Positron emission tomography, Esophagectomy, 030220 oncology & carcinogenesis, GASTROESOPHAGEAL CANCER, Adenocarcinoma, 030211 gastroenterology & hepatology, Radiology, Rare cancers Radboud Institute for Health Sciences [Radboudumc 9], MRI, medicine.medical_specialty, DCE-MRI, PET-CT, lcsh:RC254-282, 03 medical and health sciences, POSITRON-EMISSION-TOMOGRAPHY, DW-MRI, Preoperative Care, medicine, Genetics, Humans, Esophagus, JUNCTIONAL CANCER, business.industry, PERIOPERATIVE CHEMOTHERAPY, ctDNA, medicine.disease, CIRCULATING TUMOR-CELLS, business, Follow-Up Studies
Abstract

Contains fulltext : 200332.pdf (Publisher’s version ) (Open Access) BACKGROUND: Nearly one third of patients undergoing neoadjuvant chemoradiotherapy (nCRT) for locally advanced esophageal cancer have a pathologic complete response (pCR) of the primary tumor upon histopathological evaluation of the resection specimen. The primary aim of this study is to develop a model that predicts the probability of pCR to nCRT in esophageal cancer, based on diffusion-weighted magnetic resonance imaging (DW-MRI), dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and (18)F-fluorodeoxyglucose positron emission tomography with computed tomography ((18)F-FDG PET-CT). Accurate response prediction could lead to a patient-tailored approach with omission of surgery in the future in case of predicted pCR or additional neoadjuvant treatment in case of non-pCR. METHODS: The PRIDE study is a prospective, single arm, observational multicenter study designed to develop a multimodal prediction model for histopathological response to nCRT for esophageal cancer. A total of 200 patients with locally advanced esophageal cancer - of which at least 130 patients with adenocarcinoma and at least 61 patients with squamous cell carcinoma - scheduled to receive nCRT followed by esophagectomy will be included. The primary modalities to be incorporated in the prediction model are quantitative parameters derived from MRI and (18)F-FDG PET-CT scans, which will be acquired at fixed intervals before, during and after nCRT. Secondary modalities include blood samples for analysis of the presence of circulating tumor DNA (ctDNA) at 3 time-points (before, during and after nCRT), and an endoscopy with (random) bite-on-bite biopsies of the primary tumor site and other suspected lesions in the esophagus as well as an endoscopic ultrasonography (EUS) with fine needle aspiration of suspected lymph nodes after finishing nCRT. The main study endpoint is the performance of the model for pCR prediction. Secondary endpoints include progression-free and overall survival. DISCUSSION: If the multimodal PRIDE concept provides high predictive performance for pCR, the results of this study will play an important role in accurate identification of esophageal cancer patients with a pCR to nCRT. These patients might benefit from a patient-tailored approach with omission of surgery in the future. Vice versa, patients with non-pCR might benefit from additional neoadjuvant treatment, or ineffective therapy could be stopped. TRIAL REGISTRATION: The article reports on a health care intervention on human participants and was prospectively registered on March 22, 2018 under ClinicalTrials.gov Identifier: NCT03474341 .

Published
2018

35. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy versus palliative systemic chemotherapy in stomach cancer patients with peritoneal dissemination, the study protocol of a multicentre randomised controlled trial (PERISCOPE II)

Author

Koemans, W. J., primary, van der Kaaij, R. T., additional, Boot, H., additional, Buffart, T., additional, Veenhof, A. A. F. A., additional, Hartemink, K. J., additional, Grootscholten, C., additional, Snaebjornsson, P., additional, Retel, V. P., additional, van Tinteren, H., additional, Vanhoutvin, S., additional, van der Noort, V., additional, Houwink, A., additional, Hahn, C., additional, Huitema, A. D. R., additional, Lahaye, M., additional, Los, M., additional, van den Barselaar, P., additional, Imhof, O., additional, Aalbers, A., additional, van Dam, G. M., additional, van Etten, B., additional, Wijnhoven, B. P. L., additional, Luyer, M. D. P., additional, Boerma, D., additional, and van Sandick, J. W., additional

Published
2019
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37. Evaluation of PET and laparoscopy in STagIng advanced gastric cancer : A multicenter prospective study (PLASTIC-study)

Author

Brenkman, H. J.F., Gertsen, E. C., Vegt, E., van Hillegersberg, R., van Berge Henegouwen, M. I., Gisbertz, S. S., Luyer, M. D.P., Nieuwenhuijzen, G. A.P., van Lanschot, J. J.B., Lagarde, S. M., de Steur, W. O., Hartgrink, H. H., Stoot, J. H.M.B., Hulsewe, K. W.E., Spillenaar Bilgen, E. J., van Det, M. J., Kouwenhoven, E. A., van der Peet, D. L., Daams, F., van Sandick, J. W., van Grieken, N. C.T., Heisterkamp, J., van Etten, B., Haveman, J. W., Pierie, J. P., Jonker, F., Thijssen, A. Y., Belt, E. J.T., van Duijvendijk, P., Wassenaar, E., van Laarhoven, H. W.M., Wessels, F. J., Haj Mohammad, N., van Stel, H. F., Frederix, G. W.J., Siersema, P. D., Ruurda, J. P., on behalf of the PLASTIC Study Group, Brenkman, H. J.F., Gertsen, E. C., Vegt, E., van Hillegersberg, R., van Berge Henegouwen, M. I., Gisbertz, S. S., Luyer, M. D.P., Nieuwenhuijzen, G. A.P., van Lanschot, J. J.B., Lagarde, S. M., de Steur, W. O., Hartgrink, H. H., Stoot, J. H.M.B., Hulsewe, K. W.E., Spillenaar Bilgen, E. J., van Det, M. J., Kouwenhoven, E. A., van der Peet, D. L., Daams, F., van Sandick, J. W., van Grieken, N. C.T., Heisterkamp, J., van Etten, B., Haveman, J. W., Pierie, J. P., Jonker, F., Thijssen, A. Y., Belt, E. J.T., van Duijvendijk, P., Wassenaar, E., van Laarhoven, H. W.M., Wessels, F. J., Haj Mohammad, N., van Stel, H. F., Frederix, G. W.J., Siersema, P. D., Ruurda, J. P., and on behalf of the PLASTIC Study Group

Published
2018

38. Preoperative image-guided identification of response to neoadjuvant chemoradiotherapy in esophageal cancer (PRIDE): A multicenter observational study

Author

Onderzoek Radiotherapie, MS Radiotherapie, Cancer, Pathologie Pathologen staf, Fysica Radiotherapie Research, Divisie Beeld & Oncologie, Researchgr. Nucleaire Geneeskunde, Arts-assistenten Radiotherapie, MS CGO, MS MDL 1, Klinische Fysica RT, Verpleegafdeling Hematologie, Unit D (laboranten rath), Trialbureau Beeld, Epi Kanker Team A, Circulatory Health, JC onderzoeksprogramma Kanker, MS Radiologie, Borggreve, A. S., Mook, S., Verheij, M., Mul, V. E.M., Bergman, J. J., Bartels-Rutten, A., Ter Beek, L. C., Beets-Tan, R. G.H., Bennink, R. J., Van Berge Henegouwen, M. I., Brosens, L. A.A., Defize, I. L., Van Dieren, J. M., Dijkstra, H., Van Hillegersberg, R., Hulshof, M. C., Van Laarhoven, H. W.M., Lam, M. G.E.H., Van Lier, A. L.H.M.W., Muijs, C. T., Nagengast, W. B., Nederveen, A. J., Noordzij, W., Plukker, J. T.M., Van Rossum, P. S.N., Ruurda, J. P., Van Sandick, J. W., Weusten, B. L.A.M., Voncken, F. E.M., Yakar, D., Meijer, G. J., Aleman, B. M.P., Borra, R. J.H., Van Etten, B., Gisbertz, S. S., Goense, L., Haj Mohammad, N., Hartemink, K. J., Kappert, P., Kats-Ugurlu, G., Kodach, L. L., Korteweg, T., Krishnadath, K. K., Langendijk, J. A., De Leng, W. W.J., Meijer, S. L., Potze, J. H., Stoker, J., Vegt, E., Verkooijen, H. M., Vollenbrock, S. E., Wessels, F., Onderzoek Radiotherapie, MS Radiotherapie, Cancer, Pathologie Pathologen staf, Fysica Radiotherapie Research, Divisie Beeld & Oncologie, Researchgr. Nucleaire Geneeskunde, Arts-assistenten Radiotherapie, MS CGO, MS MDL 1, Klinische Fysica RT, Verpleegafdeling Hematologie, Unit D (laboranten rath), Trialbureau Beeld, Epi Kanker Team A, Circulatory Health, JC onderzoeksprogramma Kanker, MS Radiologie, Borggreve, A. S., Mook, S., Verheij, M., Mul, V. E.M., Bergman, J. J., Bartels-Rutten, A., Ter Beek, L. C., Beets-Tan, R. G.H., Bennink, R. J., Van Berge Henegouwen, M. I., Brosens, L. A.A., Defize, I. L., Van Dieren, J. M., Dijkstra, H., Van Hillegersberg, R., Hulshof, M. C., Van Laarhoven, H. W.M., Lam, M. G.E.H., Van Lier, A. L.H.M.W., Muijs, C. T., Nagengast, W. B., Nederveen, A. J., Noordzij, W., Plukker, J. T.M., Van Rossum, P. S.N., Ruurda, J. P., Van Sandick, J. W., Weusten, B. L.A.M., Voncken, F. E.M., Yakar, D., Meijer, G. J., Aleman, B. M.P., Borra, R. J.H., Van Etten, B., Gisbertz, S. S., Goense, L., Haj Mohammad, N., Hartemink, K. J., Kappert, P., Kats-Ugurlu, G., Kodach, L. L., Korteweg, T., Krishnadath, K. K., Langendijk, J. A., De Leng, W. W.J., Meijer, S. L., Potze, J. H., Stoker, J., Vegt, E., Verkooijen, H. M., Vollenbrock, S. E., and Wessels, F.

Published
2018

39. Evaluation of PET and laparoscopy in STagIng advanced gastric cancer: A multicenter prospective study (PLASTIC-study)

Author

MS CGO, Cancer, Divisie Beeld & Oncologie, MS Radiologie, MS Medische Oncologie, Verplegingswetenschap, Other research (not in main researchprogram), JC onderzoeksprogramma Methodologie, HEE, Child Health, Brenkman, H. J.F., Gertsen, E. C., Vegt, E., van Hillegersberg, R., van Berge Henegouwen, M. I., Gisbertz, S. S., Luyer, M. D.P., Nieuwenhuijzen, G. A.P., van Lanschot, J. J.B., Lagarde, S. M., de Steur, W. O., Hartgrink, H. H., Stoot, J. H.M.B., Hulsewe, K. W.E., Spillenaar Bilgen, E. J., van Det, M. J., Kouwenhoven, E. A., van der Peet, D. L., Daams, F., van Sandick, J. W., van Grieken, N. C.T., Heisterkamp, J., van Etten, B., Haveman, J. W., Pierie, J. P., Jonker, F., Thijssen, A. Y., Belt, E. J.T., van Duijvendijk, P., Wassenaar, E., van Laarhoven, H. W.M., Wessels, F. J., Haj Mohammad, N., van Stel, H. F., Frederix, G. W.J., Siersema, P. D., Ruurda, J. P., on behalf of the PLASTIC Study Group, MS CGO, Cancer, Divisie Beeld & Oncologie, MS Radiologie, MS Medische Oncologie, Verplegingswetenschap, Other research (not in main researchprogram), JC onderzoeksprogramma Methodologie, HEE, Child Health, Brenkman, H. J.F., Gertsen, E. C., Vegt, E., van Hillegersberg, R., van Berge Henegouwen, M. I., Gisbertz, S. S., Luyer, M. D.P., Nieuwenhuijzen, G. A.P., van Lanschot, J. J.B., Lagarde, S. M., de Steur, W. O., Hartgrink, H. H., Stoot, J. H.M.B., Hulsewe, K. W.E., Spillenaar Bilgen, E. J., van Det, M. J., Kouwenhoven, E. A., van der Peet, D. L., Daams, F., van Sandick, J. W., van Grieken, N. C.T., Heisterkamp, J., van Etten, B., Haveman, J. W., Pierie, J. P., Jonker, F., Thijssen, A. Y., Belt, E. J.T., van Duijvendijk, P., Wassenaar, E., van Laarhoven, H. W.M., Wessels, F. J., Haj Mohammad, N., van Stel, H. F., Frederix, G. W.J., Siersema, P. D., Ruurda, J. P., and on behalf of the PLASTIC Study Group

Published
2018

40. Exploiting metabolic acidosis in solid cancers using a tumor-agnostic pH-activatable nanoprobe for fluorescence-guided surgery.

Author

Voskuil, F. J., Steinkamp, P. J., Zhao, T., van der Vegt, B., Koller, M., Doff, J. J., Jayalakshmi, Y., Hartung, J. P., Gao, J., Sumer, B. D., Witjes, M. J. H., van Dam, G. M., the SHINE study group, Albaroodi, Y., Been, L. B., Dijkstra, F., van Etten, B., Feng, Q., van Ginkel, R. J., and Hall, K.

Subjects
ACIDOSIS, CLINICAL trial registries, CANCER, INDOCYANINE green, TUMOR microenvironment
Abstract

Cancer cell metabolism leads to a uniquely acidic microenvironment in solid tumors, but exploiting the labile extracellular pH differences between cancer and normal tissues for clinical use has been challenging. Here we describe the clinical translation of ONM-100, a nanoparticle-based fluorescent imaging agent. This is comprised of an ultra-pH sensitive amphiphilic polymer, conjugated with indocyanine green, which rapidly and irreversibly dissociates to fluoresce in the acidic extracellular tumor microenvironment due to the mechanism of nanoscale macromolecular cooperativity. Primary outcomes were safety, pharmacokinetics and imaging feasilibity of ONM-100. Secondary outcomes were to determine a range of safe doses of ONM-100 for intra-operative imaging using commonly used fluorescence camera systems. In this study (Netherlands National Trial Register #7085), we report that ONM-100 was well tolerated, and four solid tumor types could be visualized both in- and ex vivo in thirty subjects. ONM-100 enables detection of tumor-positive resection margins in 9/9 subjects and four additional otherwise missed occult lesions. Consequently, this pH-activatable optical imaging agent may be clinically beneficial in differentiating previously unexploitable narrow physiologic differences. It is well known that the pH of tumor tissue is lower than that of the corresponding normal adjacent tissue. Here, the authors report a clinical trial of a pH activatable nanoparticle for imaging tumours. [ABSTRACT FROM AUTHOR]

Published
2020
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43. False positive findings on 6-[18F]fluor-L-3,4-dihydroxyphenylalanine Positron Emission Tomography (18F-FDOPA-PET) performed for imaging of neuroendocrine tumors

Author

Berends, MA, primary, Bolt, JW, additional, Kerstens, MN, additional, Links, TP, additional, Korpershoek, E, additional, de, Krijger RR, additional, Walenkamp, AME, additional, Noordzij, W, additional, van, Etten B, additional, Kats-Urgurlu, G, additional, Brouwers, AH, additional, and van, der Horst-Schrivers ANA, additional

Published
2017
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44. Esophageal and Gastric Cancer Pearl: a nationwide clinical biobanking project in the Netherlands

Author

Haverkamp L, Parry K, Mi, Berge Henegouwen, Hw, Laarhoven, Jj, Bonenkamp, Tm, Bisseling, Pd, Siersema, Mn, Sosef, Jan Stoot, Gl, Beets, Wo, Steur, Hh, Hartgrink, Hw, Verspaget, Dl, Peet, Jt, Plukker, van Etten B, Bp, Wijnhoven, Jj, Lanschot, van Hillegersberg R, and Jp, Ruurda

Subjects
Male, Academic Medical Centers, Databases, Factual, Esophageal Neoplasms, Stomach Neoplasms, Blood Banks, Humans, Female, Prospective Studies, Tissue Banks, Neoplasm Recurrence, Local, Netherlands
Abstract

Esophageal and gastric cancer is associated with a poor prognosis since many patients develop recurrent disease. Treatment requires specific expertise and a structured multidisciplinary approach. In the Netherlands, this type of expertise is mainly found at the University Medical Centers (UMCs) and a few specialized nonacademic centers. Aim of this study is to implement a national infrastructure for research to gain more insight in the etiology and prognosis of esophageal and gastric cancer and to evaluate and improve the response on (neoadjuvant) treatment. Clinical data are collected in a prospective database, which is linked to the patients' biomaterial. The collection and storage of biomaterial is performed according to standard operating procedures in all participating UMCs as established within the Parelsnoer Institute. The collected biomaterial consists of tumor biopsies, blood samples, samples of malignant and healthy tissue of the resected specimen and biopsies of recurrence. The collected material is stored in the local biobanks and is encoded to respect the privacy of the donors. After approval of the study was obtained from the Institutional Review Board, the first patient was included in October 2014. The target aim is to include 300 patients annually. In conclusion, the eight UMCs of the Netherlands collaborated to establish a nationwide database of clinical information and biomaterial of patients with esophageal and gastric cancer. Due to the national coverage, a high number of patients are expected to be included. This will provide opportunity for future studies to gain more insight in the etiology, treatment and prognosis of esophageal and gastric cancer.

Published
2015

45. Esophageal and Gastric Cancer Pearl : a nationwide clinical biobanking project in the Netherlands

Author

Haverkamp, L, Parry, K, van Berge Henegouwen, M I, van Laarhoven, H W, Bonenkamp, J J, Bisseling, T M, Siersema, P D, Sosef, M N, Stoot, J H, Beets, G L, de Steur, W O, Hartgrink, H H, Verspaget, H W, van der Peet, D L, Plukker, J T, van Etten, B, Wijnhoven, B P L, van Lanschot, J J, van Hillegersberg, R, Ruurda, J P, Haverkamp, L, Parry, K, van Berge Henegouwen, M I, van Laarhoven, H W, Bonenkamp, J J, Bisseling, T M, Siersema, P D, Sosef, M N, Stoot, J H, Beets, G L, de Steur, W O, Hartgrink, H H, Verspaget, H W, van der Peet, D L, Plukker, J T, van Etten, B, Wijnhoven, B P L, van Lanschot, J J, van Hillegersberg, R, and Ruurda, J P

Published
2015

46. Esophageal and Gastric Cancer Pearl: a nationwide clinical biobanking project in the Netherlands

Author

MS CGO, MS MDL 1, Infection & Immunity, Cancer, MS MDL Oncologie, Divisie Beeld & Oncologie, Other research (not in main researchprogram), Haverkamp, L, Parry, K, van Berge Henegouwen, M I, van Laarhoven, H W, Bonenkamp, J J, Bisseling, T M, Siersema, P D, Sosef, M N, Stoot, J H, Beets, G L, de Steur, W O, Hartgrink, H H, Verspaget, H W, van der Peet, D L, Plukker, J T, van Etten, B, Wijnhoven, B P L, van Lanschot, J J, van Hillegersberg, R, Ruurda, J P, MS CGO, MS MDL 1, Infection & Immunity, Cancer, MS MDL Oncologie, Divisie Beeld & Oncologie, Other research (not in main researchprogram), Haverkamp, L, Parry, K, van Berge Henegouwen, M I, van Laarhoven, H W, Bonenkamp, J J, Bisseling, T M, Siersema, P D, Sosef, M N, Stoot, J H, Beets, G L, de Steur, W O, Hartgrink, H H, Verspaget, H W, van der Peet, D L, Plukker, J T, van Etten, B, Wijnhoven, B P L, van Lanschot, J J, van Hillegersberg, R, and Ruurda, J P

Published
2015

47. Surgical management of rectal gastrointestinal stromal tumors

Author

Tielen, R, Verhoef, Kees, van Coevorden, F, Reyners, AK, van der Graaf, WTA, Bonenkamp, JJ, van Etten, B (Boudewijn), de Wilt, JHW (Johannes), Guided Treatment in Optimal Selected Cancer Patients (GUTS), Targeted Gynaecologic Oncology (TARGON), and Surgery

Subjects
surgery, imatinib, Translational research [ONCOL 3], rectal, KINASE, Age-related aspects of cancer Quality of hospital and integrated care [ONCOL 2], DIAGNOSIS, neoplasms, gastrointestinal stromal tumor, Quality of Care [ONCOL 4]
Abstract

Item does not contain fulltext BACKGROUND: Five percent of gastrointestinal stromal tumors (GISTs) are primarily localized in the rectum. We analyzed the outcome of multimodality treatment for rectal GIST in a multicenter retrospective series. METHODS: All surgically treated patients with a rectal GIST were identified from four specialized centers in the Netherlands. Primary endpoints were disease-free survival (DFS) and overall survival (OS). RESULTS: Thirty-two patients (22 men and 10 women) with rectal GISTs were identified. Twenty-two patients received imatinib before surgery for a median of 9 (range 2-53) months (Group 1). Ten patients received no imatinib because of small tumor size or lack of availability (Group 2). Median tumor size before treatment was 9.3 (range 6-17) cm in Group 1 and median 6 (range 4-14) cm in Group 2. A complete resection was possible in 17/22 (77%) patients in Group 1 versus 7/10 (70%) in Group 2. Median DFS was not reached in Group 1, while it was 36 months in Group 2. Median OS was not reached in both groups. CONCLUSIONS: Preoperative imatinib leads to downsizing of the tumors in Group 1. However, it has not led to less extensive surgery. The DFS is longer in patients treated with pre- and post-operative imatinib, without an effect on OS. J. Surg. Oncol. 2013;107:320-323. (c) 2012 Wiley Periodicals, Inc.

Published
2013

49. Randomized controlled multicentre study comparing biological mesh closure of the pelvic floor with primary perineal wound closure after extralevator abdominoperineal resection for rectal cancer (BIOPEX-study)

Author

Musters, GD, Bemelman, WA, Bosker, RJI, Burger, Pim, van Duijvendijk, P, van Etten, B (Boudewijn), van Geloven, AAW, Graaf, EJR, van 't Hoff, C, de Korte, N, Leijtens, JWA, Rutten, HJT, Singh, Bharat, van de Ven, A, Vuylsteke, RJCLM, de Wilt, JHW (Johannes), Dijkgraaf, MGW, Tanis, PJ, Musters, GD, Bemelman, WA, Bosker, RJI, Burger, Pim, van Duijvendijk, P, van Etten, B (Boudewijn), van Geloven, AAW, Graaf, EJR, van 't Hoff, C, de Korte, N, Leijtens, JWA, Rutten, HJT, Singh, Bharat, van de Ven, A, Vuylsteke, RJCLM, de Wilt, JHW (Johannes), Dijkgraaf, MGW, and Tanis, PJ

Abstract

Background: Primary perineal wound closure after conventional abdominoperineal resection (cAPR) for rectal cancer has been the standard of care for many years. Since the introduction of neo-adjuvant radiotherapy and the extralevator APR (eAPR), oncological outcome has been improved, but at the cost of increased rates of perineal wound healing problems and perineal hernia. This has progressively increased the use of biological meshes, although not supported by sufficient evidence. The aim of this study is to determine the effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo) radiotherapy compared to primary perineal wound closure. Methods/Design: In this multicentre randomized controlled trial, patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo) radiotherapy will be considered eligible. Exclusion criteria are prior radiotherapy, sacral resection above S4/S5, allergy to pig products or polysorbate, collagen disorders, and severe systemic diseases affecting wound healing, except for diabetes. After informed consent, 104 patients will be randomized between standard care using primary wound closure of the perineum and the experimental arm consisting of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Patients will be followed for one year after the intervention and outcome assessors and patients will be blinded for the study treatment. The primary endpoint is the percentage of uncomplicated perineal wound healing, defined as a Southampton wound score of less than II on day 30. Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs. Discussion: The BIOPEX-study is the first randomized controlled multicentre study to determine the additive value of using a biological mesh for perineal wound closure after eAPR with neo

Published
2014

50. Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis.

Author

Bakker, I. S., Morks, A. N., ten Cate Hoedemaker, H. O., Burgerhof, J. G. M., Leuvenink, H. G., van Praagh, J. B., Ploeg, R. J., Havenga, K., van Etten, B., Lange, J. F. M., Hemmer, P. H. J., Sonneveld, D. J. A., Tanis, P. J., Wegdam, J. A., Jonk, A., Lutke Holzik, M. F., Bosker, R. J. I., Lamme, B., Spillenaar Bilgen, E. J., and Bremers, A. J.

Subjects
INTRAVASCULAR ultrasonography, SURGICAL anastomosis, PROCTOLOGY, SURGICAL wound dehiscence, ELECTIVE surgery
Abstract

Background Anastomotic leakage is a potential major complication after colorectal surgery. The C-seal was developed to help reduce the clinical leakage rate. It is an intraluminal sheath that is stapled proximal to a colorectal anastomosis, covering it intraluminally and thus preventing intestinal leakage in case of anastomotic dehiscence. The C-seal trial was initiated to evaluate the efficacy of the C-seal in reducing anastomotic leakage in stapled colorectal anastomoses. Methods This RCT was performed in 41 hospitals in the Netherlands, Germany, France, Hungary and Spain. Patients undergoing elective surgery with a stapled colorectal anastomosis less than 15 cm from the anal verge were eligible. Included patients were randomized to the C-seal and control groups, stratified for centre, anastomotic height and intention to create a defunctioning stoma. Primary outcome was anastomotic leakage requiring invasive treatment. Results Between December 2011 and December 2013, 402 patients were included in the trial, 202 in the C-seal group and 200 in the control group. Anastomotic leakage was diagnosed in 31 patients (7·7 per cent), with a 10·4 per cent leak rate in the C-seal group and 5·0 per cent in the control group ( P = 0·060). Male sex showed a trend towards a higher leak rate ( P = 0·055). Construction of a defunctioning stoma led to a lower leakage rate, although this was not significant ( P = 0·095). Conclusion C-seal application in stapled colorectal anastomoses does not reduce anastomotic leakage. Registration number: NTR3080 (). [ABSTRACT FROM AUTHOR]

Published
2017
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