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1. The Prospective Dutch Colorectal Cancer (PLCRC) cohort: real-world data facilitating research and clinical care

Author

Derksen, J.W.G. (Jeroen W. G.), Vink, G.R. (Geraldine R.), Elferink, M.A.G. (Marloes), Roodhart, J.M. (Jeanine), Verkooijen, H.M. (Helena M.), Grevenstein, H.M.U. (Helma) van, Siersema, P.D. (Peter), May, A.M. (Anne M.), Koopman, M. (Miriam), Beets, G.L. (Geerard), Belt, E.J.T. (Eric), Berbée, M. (Maaike), Beverdam, F.H. (Frederique H.), Blankenburgh, R. (Ruud), Coene, P-P. (Peter Paul), van Cruijsen, H. (Hester), Dekker, J.W.T. (Jan Willem), van Dodewaard-de Jong, J.M. (Joyce M.), Erdkamp, F.L.G. (Frans ), Groot, J.W.B. (Jan Willem) de, Haringhuizen, A.W. (Annebeth W.), Helgason, H.H. (Helgi H.), Hendriks, M.P. (Mathijs P.), Hingh, I.H.J.T. (Ignace) de, Hoekstra, R. (Ronald), IJzermans, J.N.M. (Jan), Jansen, J. (Jan), Kloppenberg, F.W.H. (Frank W. H.), Lent, A.U. (Anja) van, Los, M., Meijerink, M.R. (Martijn R.), Mekenkamp, L.J.M. (Leonie J. M.), Nieboer, P. (Peter), Peeters, K.C.M.J. (Koen C.M.J.), Peters, N.A.J.B. (Natascha A. J. B.), Polee, M.B. (Marco), Pruijt, J.F.M., Punt, C.J.A. (Cornelis), van Ufford-Mannesse, P.Q. (Patricia Quarles), Rietbroek, R.C. (Ron), Schiphorst, A.H.W. (Anandi H. W.), van der Velden, A.S. (Arjan Schouten), Schrauwen, R.W.M. (Ruud W. M.), Sie, M.P.S. (Mark P. S.), Simkens, L.H.J. (L. H J), Sommeijer, D.W. (Dirkje W.), Sonneveld, D.J.A., Spierings, L.E.A. (Leontine E. A.), Stockmann, H.B.A.C. (Hein), Talsma, A.K. (Aaldert), Terheggen, F. (Frederiek), Tije, A.J. (Albert Jan) ten, Tjin-A-Ton, M.L.R. (Manuel L. R.), Valkenburg-van Iersel, L.B.J. (Liselot B. J.), Veenstra, R.P., Velden, A.M.T. van der, Vermaas, M. (Maarten), Vles, W., Vogelaar, J.F.J. (Jeroen F. J.), van Voorthuizen, T. (Theo), Vos, A.I. (Aad) de, Wegdam, J.A. (J.), Wilt, J.H.W. (Johannes) de, Zimmerman, D.D.E. (David), Derksen, J.W.G. (Jeroen W. G.), Vink, G.R. (Geraldine R.), Elferink, M.A.G. (Marloes), Roodhart, J.M. (Jeanine), Verkooijen, H.M. (Helena M.), Grevenstein, H.M.U. (Helma) van, Siersema, P.D. (Peter), May, A.M. (Anne M.), Koopman, M. (Miriam), Beets, G.L. (Geerard), Belt, E.J.T. (Eric), Berbée, M. (Maaike), Beverdam, F.H. (Frederique H.), Blankenburgh, R. (Ruud), Coene, P-P. (Peter Paul), van Cruijsen, H. (Hester), Dekker, J.W.T. (Jan Willem), van Dodewaard-de Jong, J.M. (Joyce M.), Erdkamp, F.L.G. (Frans ), Groot, J.W.B. (Jan Willem) de, Haringhuizen, A.W. (Annebeth W.), Helgason, H.H. (Helgi H.), Hendriks, M.P. (Mathijs P.), Hingh, I.H.J.T. (Ignace) de, Hoekstra, R. (Ronald), IJzermans, J.N.M. (Jan), Jansen, J. (Jan), Kloppenberg, F.W.H. (Frank W. H.), Lent, A.U. (Anja) van, Los, M., Meijerink, M.R. (Martijn R.), Mekenkamp, L.J.M. (Leonie J. M.), Nieboer, P. (Peter), Peeters, K.C.M.J. (Koen C.M.J.), Peters, N.A.J.B. (Natascha A. J. B.), Polee, M.B. (Marco), Pruijt, J.F.M., Punt, C.J.A. (Cornelis), van Ufford-Mannesse, P.Q. (Patricia Quarles), Rietbroek, R.C. (Ron), Schiphorst, A.H.W. (Anandi H. W.), van der Velden, A.S. (Arjan Schouten), Schrauwen, R.W.M. (Ruud W. M.), Sie, M.P.S. (Mark P. S.), Simkens, L.H.J. (L. H J), Sommeijer, D.W. (Dirkje W.), Sonneveld, D.J.A., Spierings, L.E.A. (Leontine E. A.), Stockmann, H.B.A.C. (Hein), Talsma, A.K. (Aaldert), Terheggen, F. (Frederiek), Tije, A.J. (Albert Jan) ten, Tjin-A-Ton, M.L.R. (Manuel L. R.), Valkenburg-van Iersel, L.B.J. (Liselot B. J.), Veenstra, R.P., Velden, A.M.T. van der, Vermaas, M. (Maarten), Vles, W., Vogelaar, J.F.J. (Jeroen F. J.), van Voorthuizen, T. (Theo), Vos, A.I. (Aad) de, Wegdam, J.A. (J.), Wilt, J.H.W. (Johannes) de, and Zimmerman, D.D.E. (David)

Abstract

Real-world data (RWD) sources are important to advance clinical oncology research and evaluate treatments in daily practice. Since 2013, the Prospective Dutch Colorectal Cancer (PLCRC) cohort, linked to the Netherlands Cancer Registry, serves as an infrastructure for scientific research collecting additional patient-reported outcomes (PRO) and biospecimens. Here we report on cohort developments and investigate to what extent PLCRC reflects the “real-world”. Clinical and demographic characteristics of PLCRC participants were compared with the general Dutch CRC population (n = 74,692, Dutch-ref). To study representativeness, standardized differences between PLCRC and Dutch-ref were calculated, and logistic regression models were evaluated on their ability to distinguish cohort participants from the Dutch-ref (AU-ROC 0.5 = preferred, implying participation independent of patient characteristics). Stratified analyses by stage and time-period (2013–2016 and 2017–Aug 2019) were performed to study the evolution towards RWD. In August 2019, 5744 patients were enrolled. Enrollment increased steeply, from 129 participants (1 hospital) in 2013 to 2136 (50 of 75 Dutch hospitals) in 2018. Low AU-ROC (0.65, 95% CI: 0.64–0.65) indicates limited ability to distinguish cohort participants from the Dutch-ref. Characteristics that remained imbalanced in the period 2017–Aug’19 compared with the Dutch-ref were age (65.0 years in PLCRC, 69.3 in the Dutch-ref) and tumor stage (40% stage-III in PLCRC, 30% in the Dutch-ref). PLCRC approaches to represent the Dutch CRC population and will ultimately meet the current demand for high-quality RWD. Efforts are ongoing to improve multidisciplinary recruitment which will further enhance PLCRC’s representativeness and its contribution to a learning healthcare system.

Published
2021
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2. Incidence of Interval Colorectal Cancer After Negative Results From First-Round Fecal Immunochemical Screening Tests, by Cutoff Value and Participant Sex and Age

Author

Toes-Zoutendijk, E. (Esther), Kooyker, A.I. (Arthur), Dekker, E. (Evelien), Spaander, M.C.W. (Manon), Opstal-Van Winden, A. (Annemieke), Ramakers, C.R.B., Buskermolen, M. (Maaike), Vuuren, A.J. (Hanneke) van, Kuipers, E.J. (Ernst), Kemenade, F.J. (Folkert) van, Velthuysen, M.-L.F. (Marie-Louise F.), Thomeer, M.G.J. (Maarten), Van Veldhuizen, H. (Harriët), Ballegooijen, M. (Marjolein) van, Nagtegaal, I.D. (Iris), Koning, H.J. (Harry) de, Leerdam, M.E. (Monique) van, Lansdorp-Vogelaar, I. (Iris), Beek, A.J. (Allard) van der, Otte, J.A. (J. A.), Wiersma, T. (Tj.), Masclée, A.A.M. (Ad), Bergeijk, J.D. (Jeroen) van, Meijer, C.J.L.M. (Chris), Graaf, E.J.R. (Eelco) de, Grevenstein, H.M.U. (Helma) van, Frasa, M. (M.), Jacobs, L.H.J. (L. H.J.), Stoker, J. (Jacob), Vink, G. (G.), Elferink, M.A.G. (Marloes), Toes-Zoutendijk, E. (Esther), Kooyker, A.I. (Arthur), Dekker, E. (Evelien), Spaander, M.C.W. (Manon), Opstal-Van Winden, A. (Annemieke), Ramakers, C.R.B., Buskermolen, M. (Maaike), Vuuren, A.J. (Hanneke) van, Kuipers, E.J. (Ernst), Kemenade, F.J. (Folkert) van, Velthuysen, M.-L.F. (Marie-Louise F.), Thomeer, M.G.J. (Maarten), Van Veldhuizen, H. (Harriët), Ballegooijen, M. (Marjolein) van, Nagtegaal, I.D. (Iris), Koning, H.J. (Harry) de, Leerdam, M.E. (Monique) van, Lansdorp-Vogelaar, I. (Iris), Beek, A.J. (Allard) van der, Otte, J.A. (J. A.), Wiersma, T. (Tj.), Masclée, A.A.M. (Ad), Bergeijk, J.D. (Jeroen) van, Meijer, C.J.L.M. (Chris), Graaf, E.J.R. (Eelco) de, Grevenstein, H.M.U. (Helma) van, Frasa, M. (M.), Jacobs, L.H.J. (L. H.J.), Stoker, J. (Jacob), Vink, G. (G.), and Elferink, M.A.G. (Marloes)

Abstract

Background & Aims: We evaluated the incidence of interval cancers between the first and second rounds of colorectal cancer (CRC) screening with the FOB-Gold fecal immunochemical test (FIT), and the effects of different cutoff values and patient sex and age. Methods: We collected data from participants in a population-based C

Published
2020
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3. The effect of neoadjuvant short-course radiotherapy and delayed surgery versus chemoradiation on postoperative outcomes in locally advanced rectal cancer patients – A propensity score matched nationwide audit-based study

Author

Hoendervangers, S. (Sieske), Sparreboom, C.L. (Cloë), Intven, M.P.W. (M. P.W.), Lange, J.F. (Johan), Verkooijen, H.M. (Helena M.), Doornebosch, P. (Pascal), Grevenstein, H.M.U. (Helma) van, Hoendervangers, S. (Sieske), Sparreboom, C.L. (Cloë), Intven, M.P.W. (M. P.W.), Lange, J.F. (Johan), Verkooijen, H.M. (Helena M.), Doornebosch, P. (Pascal), and Grevenstein, H.M.U. (Helma) van

Abstract

Objective: To investigate differences in postoperative outcomes between short-course radiotherapy and delayed surgery (SCRT-delay) and chemoradiation (CRT) in patients with locally advanced rectal cancer (LARC). Background: Previous trials suggest that SCRT-delay could serve as an adequate neoadjuvant treatment for LARC. Therefore, in frail LARC patients SCRT-delay is recommended as an alternative to CRT. However, data on postoperative outcomes after SCRT-delay in comparison to CRT is scarce. Methods: This was an observational study with data from the Dutch ColoRectal Audit (DCRA). LARC patients who underwent surgery (2014–2017) after an interval of ≥6 weeks were included. Missing values were replaced by multiple imputation. Propensity score matching (PSM), using age, Charlson Comorbidity Index, cT-stage and surgical procedure, was applied to create comparable groups. Differences in postoperative outcomes were analyzed using Chi-square test for categorical variables, independent sample t-test for continuous variables and Mann-Whitney U test for non-parametric data. Results: 2926 patients were included. In total, 288 patients received SCRT-delay and 2638 patients underwent CRT. Patients in the SCRT-delay group were older and had more comorbidities. Also, ICU-admissions and permanent colostomies were more common, as well as pulmonic, cardiologic, infectious and neurologic complications. After PSM, both groups comprised 246 patients with equivalent age, comorbidities and tumor stage. There were no differences in postoperative complications. Conclusion: Postoperative complications were not increased in LARC patients undergoing SCRT-delay as neoadjuvant treatment. Regarding treatment-related complications, SCRT-delay is a safe alternative neoadjuvant treatment option for frail LARC patients.

Published
2020
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4. Improving clinical management of colon cancer through CONNECTION, a nation-wide colon cancer registry and stratification effort (CONNECTION II trial): rationale and protocol of a single arm intervention study

Author

van den Berg, I. (I.), van de Weerd, S. (S.), Roodhart, J.M. (Jeanine), Vink, G.R. (G. R.), Coebergh van den Braak, R.R.J. (Robert), Jimenez, C.R. (C. R.), Elias, S.G. (Sjoerd), van Vliet, D. (D.), Koelink, M. (M.), Hong, E. (E.), Grevenstein, H.M.U. (Helma) van, Oijen, M.G.H. (Martijn) van, Beets-Tan, R.G. (Regina), Van Krieken, J.H. (J. Han), IJzermans, J.N.M. (Jan), Medema, J.P. (Jan Paul), Koopman, M. (Miriam), van den Berg, I. (I.), van de Weerd, S. (S.), Roodhart, J.M. (Jeanine), Vink, G.R. (G. R.), Coebergh van den Braak, R.R.J. (Robert), Jimenez, C.R. (C. R.), Elias, S.G. (Sjoerd), van Vliet, D. (D.), Koelink, M. (M.), Hong, E. (E.), Grevenstein, H.M.U. (Helma) van, Oijen, M.G.H. (Martijn) van, Beets-Tan, R.G. (Regina), Van Krieken, J.H. (J. Han), IJzermans, J.N.M. (Jan), Medema, J.P. (Jan Paul), and Koopman, M. (Miriam)

Abstract

BACKGROUND: It is estimated that around 15-30% of patients with early stage colon cancer benefit from adjuvant chemotherapy. We are currently not capable of upfront selection of patients who benefit from chemotherapy, which indicates the need for additional predictive markers for response to chemotherapy. It has been shown that the consensus molecular subtypes (CMSs), defined by RNA-profiling, have prognostic and/or predictive value. Due to postoperative timing of chemotherapy in current guidelines, tumor response to chemotherapy per CMS is not known, which makes the differentiation between the prognostic and predictive value impossible. Therefore, we propose to assess the tumor response per CMS in the neoadjuvant chemotherapy setting. This will provide us with clear data on the predictive value for chemotherapy response of the CMSs. METHODS: In this prospective, single arm, multicenter intervention study, 262 patients with resectable microsatellite stable cT3-4NxM0 colon cancer will be treated with two courses of neoadjuvant and two courses of adjuvant capecitabine and oxaliplatin. The primary endpoint is the pathological tumor response to neoadjuvant chemotherapy per CMS. Secondary endpoints are radiological tumor response, the prognostic value of these responses for recurrence free survival and overall survival and the differences in CMS classification of the same tumor before and after neoadjuvant chemotherapy. The study is scheduled to be performed in 8-10 Dutch hospitals. T

Published
2020
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5. Nationwide comprehensive gastro-intestinal cancer cohorts: the 3P initiative

Author

Coebergh van den Braak, R.R.J. (Robert), van Rijssen, L.B. (Lennart B.), van Kleef, J.J. (J. J.), Vink, G.R. (G. R.), Berbee, M. (M.), van Berge Henegouwen, M.I., Bloemendal, H.J. (Haiko), Bruno, M.J. (Marco), Burgmans, M.C. (M. C.), Busch, O.R.C. (Olivier), Coene, P-P. (Peter Paul), Coupé, V.M.H. (Veerle), Dekker, J.W.T. (Jan Willem), Eijck, C.H.J. (Casper) van, Elferink, M.A.G. (Marloes), Erdkamp, F.L.G. (Frans ), Grevenstein, H.M.U. (Helma) van, Groot, J.W.B. (Jan Willem) de, Grieken, N.C.T. (Nicole), Hingh, I.H.J.T. (Ignace) de, Hulshof, M.C.C.M. (Maarten), IJzermans, J.N.M. (Jan), Kwakkenbos, L. (L.), Lemmens, V.E.P.P. (Valery), Los, M., Meijer, C.J.L.M. (Chris), Molenaar, I.Q. (I. Quintus), Nieuwenhuijzen, G.A.P. (Gerard), de Noo, M.E. (M. E.), Poll-Franse, L.V. (Lonneke) van de, Punt, C.J.A. (Cornelis), Rietbroek, R.C. (Ron), Roeloffzen, W.W.H. (W. W.H.), Rozema, T. (Tom), Ruurda, J.P. (Jelle), Sandick, J.W. (J.) van, Schiphorst, A.H.W. (A. H.W.), Schipper, H. (H.), Siersema, P.D. (Peter), Slingerland, M. (Marije), Sommeijer, D.W. (D. W.), Spaander, M.C.W. (Manon), Sprangers, M.A.G. (Mirjam), Stockmann, H.B.A.C. (Hein), Strijker, M. (M.), Tienhoven, G. (Geertjan) van, Timmermans, L.M. (L. M.), Tjin-a-Ton, M.L.R. (M. L.R.), Velden, A.M.T. van der, Verhaar, M.J. (M. J.), Verkooijen, H.M. (Helena M.), Vles, W., de Vos-Geelen, J. (Judith), Wilmink, J.W. (Johanna), Zimmerman, D.D.E. (David), Oijen, M.G.H. (Martijn) van, Koopman, M. (Miriam), Besselink, M.G. (Marc), Laarhoven, H.W.M. (Hanneke) van, Coebergh van den Braak, R.R.J. (Robert), van Rijssen, L.B. (Lennart B.), van Kleef, J.J. (J. J.), Vink, G.R. (G. R.), Berbee, M. (M.), van Berge Henegouwen, M.I., Bloemendal, H.J. (Haiko), Bruno, M.J. (Marco), Burgmans, M.C. (M. C.), Busch, O.R.C. (Olivier), Coene, P-P. (Peter Paul), Coupé, V.M.H. (Veerle), Dekker, J.W.T. (Jan Willem), Eijck, C.H.J. (Casper) van, Elferink, M.A.G. (Marloes), Erdkamp, F.L.G. (Frans ), Grevenstein, H.M.U. (Helma) van, Groot, J.W.B. (Jan Willem) de, Grieken, N.C.T. (Nicole), Hingh, I.H.J.T. (Ignace) de, Hulshof, M.C.C.M. (Maarten), IJzermans, J.N.M. (Jan), Kwakkenbos, L. (L.), Lemmens, V.E.P.P. (Valery), Los, M., Meijer, C.J.L.M. (Chris), Molenaar, I.Q. (I. Quintus), Nieuwenhuijzen, G.A.P. (Gerard), de Noo, M.E. (M. E.), Poll-Franse, L.V. (Lonneke) van de, Punt, C.J.A. (Cornelis), Rietbroek, R.C. (Ron), Roeloffzen, W.W.H. (W. W.H.), Rozema, T. (Tom), Ruurda, J.P. (Jelle), Sandick, J.W. (J.) van, Schiphorst, A.H.W. (A. H.W.), Schipper, H. (H.), Siersema, P.D. (Peter), Slingerland, M. (Marije), Sommeijer, D.W. (D. W.), Spaander, M.C.W. (Manon), Sprangers, M.A.G. (Mirjam), Stockmann, H.B.A.C. (Hein), Strijker, M. (M.), Tienhoven, G. (Geertjan) van, Timmermans, L.M. (L. M.), Tjin-a-Ton, M.L.R. (M. L.R.), Velden, A.M.T. van der, Verhaar, M.J. (M. J.), Verkooijen, H.M. (Helena M.), Vles, W., de Vos-Geelen, J. (Judith), Wilmink, J.W. (Johanna), Zimmerman, D.D.E. (David), Oijen, M.G.H. (Martijn) van, Koopman, M. (Miriam), Besselink, M.G. (Marc), and Laarhoven, H.W.M. (Hanneke) van

Abstract

Background: The increasing sub-classification of cancer patients due to more detailed molecular classification of tumors, and limitations of current trial designs, require innovative research designs. We present the design, governance and current standing of three comprehensive nationwide cohorts including pancreatic, esophageal/gastric, and colorectal cancer patients (NCT02070146). Multidisciplinary collection of clinical data, tumor tissue, blood samples, and patient-reported outcome (PRO) measures with a nationwide coverage, provides the infrastructure for future and novel trial designs and facilitates research to improve outcomes of gastrointestinal cancer patients. Material and methods: All patients aged ≥18 years with pancreatic, esophageal/gastric or colorectal cancer are eligible. Patients provide informed consent for: (1) reuse of clinical data; (2) biobanking of primary tumor tissue; (3) collection of blood samples; (4) to be informed about relevant newly identified genomic aberrations; (5) collection of longitudinal PROs; and (6) to receive information on new interventional studies and possible participation in cohort multiple randomized controlled trials (cmRCT) in the future. Results: In 2015, clinical data of 21,758 newly diagnosed patients were collected in the Netherlands Cancer Registry. Additional clinical data on the surgical procedures were registered in surgical audits for 13,845 patients. Within the first two years, tumor tissue and blood samples were obtained from 1507 patients; during this period, 1180 patients were included in the PRO registry. Response rate for PROs was 90%. The consent rate to receive information on new interventional studies and possible participation in cmRCTs in the future was >85%. The number of hospitals participating in the cohorts is steadily increasing. Conclusion: A comprehensive nationwide multidisciplinary gastrointestinal cancer cohort is feasible and surpasses the limitations of classical study designs. With t

Published
2018
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6. Imatinib treatment of poor prognosis mesenchymal-type primary colon cancer: A proof-of-concept study in the preoperative window period (ImPACCT)

Author

Ubink, I., Bloemendal, H.J. (Haiko), Elias, S.G. (Sjoerd), Brink, M.A. (Menno), Schwartz, M.P. (Matthijs), Holierhoek, Y.C.W., Verheijen, P.M., Boerman, A.W., Mathijssen, A.H.J. (Ron), Leng, W.W.J. (Wendy) de, Weger, R.A. (Roel) de, Grevenstein, H.M.U. (Helma) van, Koopman, M. (Miriam), Lolkema, M.P. (Martijn), Kranenburg, O. (Onno), Borel Rinkes, I.H.M. (Inne), Ubink, I., Bloemendal, H.J. (Haiko), Elias, S.G. (Sjoerd), Brink, M.A. (Menno), Schwartz, M.P. (Matthijs), Holierhoek, Y.C.W., Verheijen, P.M., Boerman, A.W., Mathijssen, A.H.J. (Ron), Leng, W.W.J. (Wendy) de, Weger, R.A. (Roel) de, Grevenstein, H.M.U. (Helma) van, Koopman, M. (Miriam), Lolkema, M.P. (Martijn), Kranenburg, O. (Onno), and Borel Rinkes, I.H.M. (Inne)

Abstract

Background: The identification of four Consensus Molecular Subtypes (CMS1-4) of colorectal cancer forms a new paradigm for the design and evaluation of subtype-directed therapeutic strategies. The most aggressive subtype - CMS4 - has the highest chance of disease recurrence. Novel adjuvant therapies for patients with CMS4 tumours are therefore urgently needed. CMS4 tumours are characterized by expression of mesenchymal and stem-like genes. Previous pre-clinical work has shown that targeting Platelet-Derived Growth Factor Receptors (PDGFRs) and the related KIT receptor with imatinib is potentially effective against mesenchymal-type colon cancer

Published
2017
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7. A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer

Author

Borstlap, W.A.A., Tanis, P.J. (Pieter), Koedam, T.W.A., Marijnen, C.A.M. (Corrie), Cunningham, C., Dekker, E. (Evelien), Leerdam, M.E. (Monique) van, Meijer, G.A., Grieken, N.C.T. (Nicole), Nagtegaal, I.D. (Iris), Punt, C.J.A. (Cornelis), Dijkgraaf, M.G.W. (Marcel), Wilt, J.H.W. (Johannes) de, Beets, G.L. (Geerard), Graaf, E.J.R. (Eelco) de, Geloven, A.A. (Anna) van, Gerhards, M.F. (Michael), van Westreenen, H.L., Van De Ven, A. (Anthony), Duijvendijk, P. (Peter) van, Hingh, I.H.J.T. (Ignace) de, Leijtens, J.W.A. (Jeroen), Sietses, C. (C.), Spillenaar Bilgen, E.J. (Ernst Jan), Vuylsteke, R.J.C.L.M., Hoff, C. (Christiaan), Burger, J.W.A. (Jacobus), Grevenstein, H.M.U. (Helma) van, Pronk, A. (Apollo), Bosker, R.J.I. (Robbert), Prins, H.A. (Hubert), Smits, A., Bruin, S.C. (Sjoerd), Zimmerman, D.D.E. (David), Stassen, L.P. (Laurents), Dunker, M.S., Westerterp, M. (Marinke), Coene, P-P. (Peter Paul), Stoot, J.H.M.B. (Jan), Bemelman, W.A., Tuynman, J.B., Borstlap, W.A.A., Tanis, P.J. (Pieter), Koedam, T.W.A., Marijnen, C.A.M. (Corrie), Cunningham, C., Dekker, E. (Evelien), Leerdam, M.E. (Monique) van, Meijer, G.A., Grieken, N.C.T. (Nicole), Nagtegaal, I.D. (Iris), Punt, C.J.A. (Cornelis), Dijkgraaf, M.G.W. (Marcel), Wilt, J.H.W. (Johannes) de, Beets, G.L. (Geerard), Graaf, E.J.R. (Eelco) de, Geloven, A.A. (Anna) van, Gerhards, M.F. (Michael), van Westreenen, H.L., Van De Ven, A. (Anthony), Duijvendijk, P. (Peter) van, Hingh, I.H.J.T. (Ignace) de, Leijtens, J.W.A. (Jeroen), Sietses, C. (C.), Spillenaar Bilgen, E.J. (Ernst Jan), Vuylsteke, R.J.C.L.M., Hoff, C. (Christiaan), Burger, J.W.A. (Jacobus), Grevenstein, H.M.U. (Helma) van, Pronk, A. (Apollo), Bosker, R.J.I. (Robbert), Prins, H.A. (Hubert), Smits, A., Bruin, S.C. (Sjoerd), Zimmerman, D.D.E. (David), Stassen, L.P. (Laurents), Dunker, M.S., Westerterp, M. (Marinke), Coene, P-P. (Peter Paul), Stoot, J.H.M.B. (Jan), Bemelman, W.A., and Tuynman, J.B.

Abstract

Background: Rectal cancer surgery is accompanied with high morbidity and poor long term functional outcome. Screening programs have shown a shift towards more early staged cancers. Patients with early rectal cancer can potentially benefit significantly from rectal preserving therapy. For the earliest stage cancers, local excision is sufficient when the risk of lymph node disease and subsequent recurrence is below 5 %. However, the majority of early cancers are associated with an intermediate risk of lymph node involvement (5-20 %) suggesting that local excision alone is not sufficient, while completion radical surgery, which is currently standard of care, could be a substantial overtreatment for this group of patients. Methods/Study design: In this multicentre randomised trial, patients with an intermediate risk T1-2 rectal cancer, that has been locally excised using an endoluminal technique, will be randomized between adjuvant chemo-radiotherapylimited to the mesorectum and standard completion total mesorectal excision (TME). To strictly monitor the risk of locoregional recurrence in the experimental arm and enable early salvage surgery, there will be additional follow up with frequent MRI and endoscopy. The primary outcome of the study is three-year local recurrence rate. Secondary outcomes are morbidity, disease free and overall survival, stoma rate, functional outcomes, health related quality of life and costs. The design is a non inferiority study with a total sample size of 302 patients. Discussion: The results of the TESAR trial will potentially demonstrate that adjuvant chemoradiotherapy is an oncological safe treatment option in patients who are confronted with the difficult clinical dilemma of a radically removed intermediate risk early rectal cancer by polypectomy or transanal surgery that is conventionally treated with subsequent radical surgery. Preserving the rectum using adjuvant radiotherapy is expected to significantly improve morbidity, function an

Published
2016
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8. Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicentre trial

Author

Klaver, C.E.L. (Charlotte), Musters, G.D. (Gijsbert), Bemelman, W.A. (Willem), Punt, C.J.A. (Cornelis), Verwaal, V.J. (Vic J.), Dijkgraaf, M.G.W. (Marcel), Aalbers, A.G.J. (Arend), van der Bilt, J.D.W. (Jarmila D.W.), Boerma, D. (Djamila), Bremers, A.J.A. (Andreas), Burger, J.W.A. (Jacobus), Buskens, C.J. (Christianne), Evers, P. (Pauline), van Ginkel, R.J. (Robert J.), Grevenstein, H.M.U. (Helma) van, Hemmer, P.H.J. (Patrick H.J.), Hingh, I.H.J.T. (Ignace) de, Lammers, L.A. (Laureen), Leeuwen, B.L. (B.) van, Meijerink, W.J.H.J. (Jeroen), Nienhuijs, S.W. (Simon), Pon, J. (Jolien), Radema, S.A. (Sandra A.), Ramshorst, B. (Bert) van, Snaebjornsson, P., Tuynman, J.B., te Velde, E.A. (Elisabeth A.), Wiezer, M.J. (Marinus), Wilt, J.H.W. (Johannes) de, Tanis, P.J. (Pieter), Klaver, C.E.L. (Charlotte), Musters, G.D. (Gijsbert), Bemelman, W.A. (Willem), Punt, C.J.A. (Cornelis), Verwaal, V.J. (Vic J.), Dijkgraaf, M.G.W. (Marcel), Aalbers, A.G.J. (Arend), van der Bilt, J.D.W. (Jarmila D.W.), Boerma, D. (Djamila), Bremers, A.J.A. (Andreas), Burger, J.W.A. (Jacobus), Buskens, C.J. (Christianne), Evers, P. (Pauline), van Ginkel, R.J. (Robert J.), Grevenstein, H.M.U. (Helma) van, Hemmer, P.H.J. (Patrick H.J.), Hingh, I.H.J.T. (Ignace) de, Lammers, L.A. (Laureen), Leeuwen, B.L. (B.) van, Meijerink, W.J.H.J. (Jeroen), Nienhuijs, S.W. (Simon), Pon, J. (Jolien), Radema, S.A. (Sandra A.), Ramshorst, B. (Bert) van, Snaebjornsson, P., Tuynman, J.B., te Velde, E.A. (Elisabeth A.), Wiezer, M.J. (Marinus), Wilt, J.H.W. (Johannes) de, and Tanis, P.J. (Pieter)

Abstract

Background: The peritoneum is the second most common site of recurrence in colorectal cancer. Early detection of peritoneal carcinomatosis (PC) by imaging is difficult. Patients eventually presenting with clinically apparent PC have a poor prognosis. Median survival is only about five months if untreated and the benefit of palliative systemic chemotherapy is limited. Only a quarter of patients are eligible for curative treatment, consisting of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CR/HIPEC). However, the effectiveness depends highly on the extent of disease and the treatment is associated with a considerable complication rate. Methods/Design: The aim of this study is to determine the effectiveness of adjuvant HIPEC in preventing the development of PC in patients with colon cancer at high risk of peritoneal recurrence. This study will be performed in the nine Dutch HIPEC centres, starting in April 2015. Eligible for inclusion are patients who underwent curative resection for T4 or intra-abdominally perforated cM0 stage colon cancer. After resection of the primary tumour, 176 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously or shortly after the primary resection. Oxaliplatin will be used as chemotherapeutic agent, for 30 min at 42-43 °C. Just before HIPEC, 5-fluorouracil and leucovorin will be administered intravenously. Primary endpoint is peritoneal disease-free survival at 18 months. Diagnostic laparoscopy will be performed routinely after 18 months postoperatively in both arms of the study in patients without evidence of disease based on routine follow-up using CT imaging and CEA. Discussion: Adjuvant HIPEC is assumed to reduce the expected 25 % absolute risk of PC in patients with T4 or perforated colon cancer to a risk of 10 %. This reduction is likely to trans

Published
2015
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9. The ladies trial: Laparoscopic peritoneal lavage or resection for purulent peritonitisA and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitisB in perforated diverticulitis (NTR2037)

Author

Swank, D.J. (Dingeman), Vermeulen, J. (Jefrey), Lange, J.F. (Johan), Mulder, I.M. (Irene), Hoeven, J.A.B. (Joost) van der, Stassen, L.P. (Laurents), Crolla, R.M.P.H. (Rogier), Sosef, M.N. (Meindert), Nienhuijs, S.W. (Simon), Bosker, R.J.I. (Robbert), Boom, M.J. (Maarten), Kruyt, Ph.M. (Philip), Steup, W.H. (Willem Hans), Graaf, E.J.R. (Eelco) de, Weidema, W.F. (Wibo), Pierik, R.E.G.J.M. (Robert), Prins, H.A. (Hubert), Stockmann, H.B.A.C., Tollenaar, R.A.E.M. (Rob), Wagensveld, B.A. (Bart) van, Coene, P-P. (Peter Paul), Slooter, G.D. (Gerrit), Consten, E.C. (Esther), Duijn, E.B. (Eino) van, Gerhards, M.F. (Michael), Hoofwijk, A.G.M. (Anton), Karsten, T.M. (Thomas), Neijenhuis, P.A. (Peter), Blanken-Peeters, C.F.J.M. (Charlotte), Cense, H.A. (Huib), Mannaerts, G.H.H. (Guido), Bruin, S.C. (Sjoerd), Eijsbouts, Q.A. (Quirijn), Wiezer, M.J. (Marinus), Hazebroek, E.J. (Eric Jasper), Geloven, A.A. (Anna) van, Maring, J.K. (John), D'Hoore, A. (André), Kartheuser, A. (Alex), Remue, C. (Christophe), Grevenstein, H.M.U. (Helma) van, Konsten, J.L.M. (Joop), Peet, D.L. (Donald) van der, Govaert, M.J.P.M. (Marc), Engel, A.F. (Alexander), Reitsma, J.B. (Johannes), Bemelman, W.A. (Willem), Swank, D.J. (Dingeman), Vermeulen, J. (Jefrey), Lange, J.F. (Johan), Mulder, I.M. (Irene), Hoeven, J.A.B. (Joost) van der, Stassen, L.P. (Laurents), Crolla, R.M.P.H. (Rogier), Sosef, M.N. (Meindert), Nienhuijs, S.W. (Simon), Bosker, R.J.I. (Robbert), Boom, M.J. (Maarten), Kruyt, Ph.M. (Philip), Steup, W.H. (Willem Hans), Graaf, E.J.R. (Eelco) de, Weidema, W.F. (Wibo), Pierik, R.E.G.J.M. (Robert), Prins, H.A. (Hubert), Stockmann, H.B.A.C., Tollenaar, R.A.E.M. (Rob), Wagensveld, B.A. (Bart) van, Coene, P-P. (Peter Paul), Slooter, G.D. (Gerrit), Consten, E.C. (Esther), Duijn, E.B. (Eino) van, Gerhards, M.F. (Michael), Hoofwijk, A.G.M. (Anton), Karsten, T.M. (Thomas), Neijenhuis, P.A. (Peter), Blanken-Peeters, C.F.J.M. (Charlotte), Cense, H.A. (Huib), Mannaerts, G.H.H. (Guido), Bruin, S.C. (Sjoerd), Eijsbouts, Q.A. (Quirijn), Wiezer, M.J. (Marinus), Hazebroek, E.J. (Eric Jasper), Geloven, A.A. (Anna) van, Maring, J.K. (John), D'Hoore, A. (André), Kartheuser, A. (Alex), Remue, C. (Christophe), Grevenstein, H.M.U. (Helma) van, Konsten, J.L.M. (Joop), Peet, D.L. (Donald) van der, Govaert, M.J.P.M. (Marc), Engel, A.F. (Alexander), Reitsma, J.B. (Johannes), and Bemelman, W.A. (Willem)

Abstract

Background: Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy. The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis). Methods/Design: In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power

Published
2010
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