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9. Towards Response ADAptive Radiotherapy for organ preservation for intermediate-risk rectal cancer (preRADAR): protocol of a phase I dose-escalation trial

Author

Verweij, Maaike E, primary, Tanaka, Max D, additional, Kensen, Chavelli M, additional, van der Heide, Uulke A, additional, Marijnen, Corrie A M, additional, Janssen, Tomas, additional, Vijlbrief, Tineke, additional, van Grevenstein, Wilhelmina M U, additional, Moons, Leon M G, additional, Koopman, Miriam, additional, Lacle, Miangela M, additional, Braat, Manon N G J A, additional, Chalabi, Myriam, additional, Maas, Monique, additional, Huibregtse, Inge L, additional, Snaebjornsson, Petur, additional, Grotenhuis, Brechtje A, additional, Fijneman, Remond, additional, Consten, Esther, additional, Pronk, Apollo, additional, Smits, Anke B, additional, Heikens, Joost T, additional, Eijkelenkamp, Hidde, additional, Elias, Sjoerd G, additional, Verkooijen, Helena M, additional, Schoenmakers, Maartje M C, additional, Meijer, Gert J, additional, Intven, Martijn, additional, and Peters, Femke P, additional

Published
2023
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10. Radiotherapy quality assurance for mesorectum treatment planning within the multi-center phase II STAR-TReC trial: Dutch results

Author

van den Ende, Roy P. J., Peters, Femke P., Harderwijk, Ernst, Rütten, Heidi, Bouwmans, Liza, Berbee, Maaike, Canters, Richard A. M., Stoian, Georgiana, Compagner, Kim, Rozema, Tom, de Smet, Mariska, Intven, Martijn P. W., Tijssen, Rob H. N., Theuws, Jacqueline, van Haaren, Paul, van Triest, Baukelien, Eekhout, Dave, Marijnen, Corrie A. M., van der Heide, Uulke A., and Kerkhof, Ellen M.

Published
2020
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11. Long-term Quality of Life and Functional Outcome of Patients With Rectal Cancer Following a Watch-and-Wait Approach

Author

Custers, Petra A., van der Sande, Marit E., Grotenhuis, Brechtje A., Peters, Femke P., van Kuijk, Sander M. J., Beets, Geerard L., Breukink, Stephanie O., Dutch Watch & Wait Consortium, Custers, Petra A., van der Sande, Marit E., Grotenhuis, Brechtje A., Peters, Femke P., van Kuijk, Sander M. J., Beets, Geerard L., Breukink, Stephanie O., and Dutch Watch & Wait Consortium

Abstract

IMPORTANCE A watch-and-wait approach for patients with rectal cancer and a clinical complete response after neoadjuvant chemoradiotherapy or radiotherapy is associated with better quality of life and functional outcome. Nevertheless, prospective data on both parameters are scarce.OBJECTIVE To prospectively evaluate quality of life and functional outcome, including bowel, urinary, and sexual function, of patients following a watch-and-wait approach. DESIGN, SETTING, AND PARTICIPANTS A total of 278 patients with rectal cancer and a clinical complete response or near-complete response after neoadjuvant chemoradiotherapy or radiotherapy were included in 2 prospective cohort studies: a single-center study (March 2014 to October 2017) and an ongoing multicenter study (from September 2017). Patients were observed by a watch-and-wait approach. Additional local excision or total mesorectal excision was performed for residual disease or regrowth. Data were analyzed between April 1, 2021, and August 27, 2021, for patients with a minimum follow-up of 24 months.MAIN OUTCOMES AND MEASURES Quality of life was evaluated with the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-C30 (EORTC-QLQ-C30), EORTC-QLQ-CR38, or EORTC-QLQ-CR29 and 36-Item Short-Form Health Survey. The score for the questionnaires and 36-Item Short-Form Health Survey ranges from 0 to 100. For some scales, a high score indicates a high level of functioning, and for others it indicates a high level of complaints and symptomatology. Functional outcome was assessed by the Low Anterior Resection Syndrome score, Vaizey incontinence score, International Prostate Symptom Score, International Index of Erectile Function, and Female Sexual Function Index.RESULTS Of 278 patients included, 187 were male (67%), and the median age was 66 years (range, 34-85 years). In the first 24 months, 221 patients (80%) were observed by a watch-and-wait approach without requiring surgery, 18 patients

Published
2023

12. Treatment of locally advanced rectal cancer and synchronous liver metastases:multicentre comparison of two treatment strategies

Author

van Rees, Jan M., Krul, Myrtle F., Kok, Niels F.M., Grünhagen, Dirk J., Kok, E. N.D., Nierop, Pieter M.H., Havenga, Klaas, Rutten, Harm, Burger, Jacobus W.A., de Wilt, Johannes H.W., Hagendoorn, Jeroen, Peters, Femke P., Buijsen, Johannes, Tanis, Pieter J., Verhoef, Cornelis, Kuhlmann, Koert F.D., van Rees, Jan M., Krul, Myrtle F., Kok, Niels F.M., Grünhagen, Dirk J., Kok, E. N.D., Nierop, Pieter M.H., Havenga, Klaas, Rutten, Harm, Burger, Jacobus W.A., de Wilt, Johannes H.W., Hagendoorn, Jeroen, Peters, Femke P., Buijsen, Johannes, Tanis, Pieter J., Verhoef, Cornelis, and Kuhlmann, Koert F.D.

Published
2023

13. Treatment of locally advanced rectal cancer and synchronous liver metastases: multicentre comparison of two treatment strategies

Author

Cancer, MS CGO, Van Rees, Jan M., Krul, Myrtle F., Kok, Niels F.M., Grünhagen, Dirk J., Kok, E. N.D., Nierop, Pieter M.H., Havenga, Klaas, Rutten, Harm, Burger, Jacobus W.A., De Wilt, Johannes H.W., Hagendoorn, Jeroen, Peters, Femke P., Buijsen, Johannes, Tanis, Pieter J., Verhoef, Cornelis, Kuhlmann, Koert F.D., Cancer, MS CGO, Van Rees, Jan M., Krul, Myrtle F., Kok, Niels F.M., Grünhagen, Dirk J., Kok, E. N.D., Nierop, Pieter M.H., Havenga, Klaas, Rutten, Harm, Burger, Jacobus W.A., De Wilt, Johannes H.W., Hagendoorn, Jeroen, Peters, Femke P., Buijsen, Johannes, Tanis, Pieter J., Verhoef, Cornelis, and Kuhlmann, Koert F.D.

Published
2023

14. Towards Response ADAptive Radiotherapy for organ preservation for intermediate-risk rectal cancer (preRADAR): protocol of a phase I dose-escalation trial

Author

Trialbureau Beeld, Cancer, MS CGO, MS MDL 1, MS Medische Oncologie, Pathologie Pathologen staf, MS Radiologie, Epi Kanker Team C, JC onderzoeksprogramma Kanker, Klinische Fysica RT, MS Radiotherapie, Verweij, Maaike E, Tanaka, Max D, Kensen, Chavelli M, van der Heide, Uulke A, Marijnen, Corrie A M, Janssen, Tomas, Vijlbrief, Tineke, van Grevenstein, Wilhelmina M U, Moons, Leon M G, Koopman, Miriam, Lacle, Miangela M, Braat, Manon N G J A, Chalabi, Myriam, Maas, Monique, Huibregtse, Inge L, Snaebjornsson, Petur, Grotenhuis, Brechtje A, Fijneman, Remond, Consten, Esther, Pronk, Apollo, Smits, Anke B, Heikens, Joost T, Eijkelenkamp, Hidde, Elias, Sjoerd G, Verkooijen, Helena M, Schoenmakers, Maartje M C, Meijer, Gert J, Intven, Martijn, Peters, Femke P, Trialbureau Beeld, Cancer, MS CGO, MS MDL 1, MS Medische Oncologie, Pathologie Pathologen staf, MS Radiologie, Epi Kanker Team C, JC onderzoeksprogramma Kanker, Klinische Fysica RT, MS Radiotherapie, Verweij, Maaike E, Tanaka, Max D, Kensen, Chavelli M, van der Heide, Uulke A, Marijnen, Corrie A M, Janssen, Tomas, Vijlbrief, Tineke, van Grevenstein, Wilhelmina M U, Moons, Leon M G, Koopman, Miriam, Lacle, Miangela M, Braat, Manon N G J A, Chalabi, Myriam, Maas, Monique, Huibregtse, Inge L, Snaebjornsson, Petur, Grotenhuis, Brechtje A, Fijneman, Remond, Consten, Esther, Pronk, Apollo, Smits, Anke B, Heikens, Joost T, Eijkelenkamp, Hidde, Elias, Sjoerd G, Verkooijen, Helena M, Schoenmakers, Maartje M C, Meijer, Gert J, Intven, Martijn, and Peters, Femke P

Published
2023

16. Features on Endoscopy and MRI after Treatment with Contact X-ray Brachytherapy for Rectal Cancer: Explorative Results

Author

Custers, Petra A., primary, Maas, Monique, additional, Lambregts, Doenja M. J., additional, Beets-Tan, Regina G. H., additional, Beets, Geerard L., additional, Peters, Femke P., additional, Marijnen, Corrie A. M., additional, van Leerdam, Monique E., additional, Huibregtse, Inge L., additional, and van Triest, Baukelien, additional

Published
2022
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19. Clinical Outcomes after International Referral of Uveal Melanoma Patients for Proton Therapy

Author

Marinkovic, Marina, primary, Pors, Lennart J., additional, van den Berg, Vincent, additional, Peters, Femke P., additional, Schalenbourg, Ann, additional, Zografos, Leonidas, additional, Pica, Alessia, additional, Hrbacek, Jan, additional, Van Duinen, Sjoerd G., additional, Vu, T. H. Khanh, additional, Bleeker, Jaco C., additional, Rasch, Coen R. N., additional, Jager, Martine J., additional, Luyten, Gregorius P. M., additional, and Horeweg, Nanda, additional

Published
2021
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20. Planning target volume margin assessment for online adaptive MR-guided dose-escalation in rectal cancer on a 1.5 T MR-Linac

Author

Cancer, Onderzoek Radiotherapie, Fysica Radiotherapie Research, Trialbureau Beeld, Klinische Fysica RT, MS Radiotherapie, Eijkelenkamp, Hidde, Boekhoff, Mick R, Verweij, Maaike E, Peters, Femke P, Meijer, Gert J, Intven, Martijn P W, Cancer, Onderzoek Radiotherapie, Fysica Radiotherapie Research, Trialbureau Beeld, Klinische Fysica RT, MS Radiotherapie, Eijkelenkamp, Hidde, Boekhoff, Mick R, Verweij, Maaike E, Peters, Femke P, Meijer, Gert J, and Intven, Martijn P W

Published
2021

22. Radiotherapy quality assurance for mesorectum treatment planning within the multi-center phase II STAR-TReC trial: Dutch results

Author

Ende, Roy P.J. van den, Peters, Femke P., Harderwijk, Ernst, Rutten, H., Bouwmans, Liza, Berbee, Maaike, Heide, Uulke A. van der, Kerkhof, Ellen M., Ende, Roy P.J. van den, Peters, Femke P., Harderwijk, Ernst, Rutten, H., Bouwmans, Liza, Berbee, Maaike, Heide, Uulke A. van der, and Kerkhof, Ellen M.

Abstract

Contains fulltext : 217402.pdf (publisher's version ) (Open Access)

Published
2020

23. Radiotherapy quality assurance for mesorectum treatment planning within the multi-center phase II STAR-TReC trial : Dutch results

Author

Van Den Ende, Roy P.J., Peters, Femke P., Harderwijk, Ernst, Rütten, Heidi, Bouwmans, Liza, Berbee, Maaike, Canters, Richard A.M., Stoian, Georgiana, Compagner, Kim, Rozema, Tom, De Smet, Mariska, Intven, Martijn P.W., Tijssen, Rob H.N., Theuws, Jacqueline, Van Haaren, Paul, Van Triest, Baukelien, Eekhout, Dave, Marijnen, Corrie A.M., Van Der Heide, Uulke A., Kerkhof, Ellen M., Van Den Ende, Roy P.J., Peters, Femke P., Harderwijk, Ernst, Rütten, Heidi, Bouwmans, Liza, Berbee, Maaike, Canters, Richard A.M., Stoian, Georgiana, Compagner, Kim, Rozema, Tom, De Smet, Mariska, Intven, Martijn P.W., Tijssen, Rob H.N., Theuws, Jacqueline, Van Haaren, Paul, Van Triest, Baukelien, Eekhout, Dave, Marijnen, Corrie A.M., Van Der Heide, Uulke A., and Kerkhof, Ellen M.

Published
2020

24. Radiotherapy quality assurance for mesorectum treatment planning within the multi-center phase II STAR-TReC trial: Dutch results

Author

MS Radiotherapie, Cancer, Klinische Fysica RT, Van Den Ende, Roy P.J., Peters, Femke P., Harderwijk, Ernst, Rütten, Heidi, Bouwmans, Liza, Berbee, Maaike, Canters, Richard A.M., Stoian, Georgiana, Compagner, Kim, Rozema, Tom, De Smet, Mariska, Intven, Martijn P.W., Tijssen, Rob H.N., Theuws, Jacqueline, Van Haaren, Paul, Van Triest, Baukelien, Eekhout, Dave, Marijnen, Corrie A.M., Van Der Heide, Uulke A., Kerkhof, Ellen M., MS Radiotherapie, Cancer, Klinische Fysica RT, Van Den Ende, Roy P.J., Peters, Femke P., Harderwijk, Ernst, Rütten, Heidi, Bouwmans, Liza, Berbee, Maaike, Canters, Richard A.M., Stoian, Georgiana, Compagner, Kim, Rozema, Tom, De Smet, Mariska, Intven, Martijn P.W., Tijssen, Rob H.N., Theuws, Jacqueline, Van Haaren, Paul, Van Triest, Baukelien, Eekhout, Dave, Marijnen, Corrie A.M., Van Der Heide, Uulke A., and Kerkhof, Ellen M.

Published
2020

25. T 1ρ for Radiotherapy Treatment Response Monitoring in Rectal Cancer Patients: A Pilot Study.

Author

Kooreman, Ernst S., Tanaka, Max, ter Beek, Leon C., Peters, Femke P., Marijnen, Corrie A. M., van der Heide, Uulke A., and van Houdt, Petra J.

Subjects
RECTAL cancer, CANCER patients, PILOT projects, LINEAR accelerators, RADIOTHERAPY
Abstract

Quantitative MRI has the potential to produce imaging biomarkers for the prediction of early response to radiotherapy treatment. In this pilot study, a potential imaging biomarker, the T1ρ relaxation time, is assessed for this purpose. A T1ρ sequence was implemented on a 1.5 T MR-linac system, a system that combines an MRI with a linear accelerator for radiation treatment. An agar phantom with concentrations of 1–4% w/w was constructed for technical validation of the sequence. Phantom images were assessed in terms of short-term repeatability and signal-to-noise ratio. Twelve rectal cancer patients, who were treated with 5 × 5 Gy, were imaged on each treatment fraction. Individual changes in the T1ρ values of the gross tumor volume (GTV) showed an increase for most patients, although a paired t-test comparing values in the GTV from the first to the last treatment fraction showed no statistically significant difference. The phantom measurements showed excellent short-term repeatability (0.5–1.5 ms), and phantom T1ρ values corresponded to the literature values. T1ρ imaging was implemented successfully on the MR-linac, with a repeatability comparable to diagnostic systems, although clinical benefit in terms of treatment response monitoring remains to be demonstrated. [ABSTRACT FROM AUTHOR]

Published
2022
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26. Management of conjunctival melanoma with local excision and adjuvant brachytherapy

Author

Brouwer, Niels J., primary, Marinkovic, Marina, additional, Peters, Femke P., additional, Hulshof, Maarten C. C. M., additional, Pieters, Bradley R., additional, de Keizer, Rob J. W., additional, Horeweg, Nanda, additional, Laman, Mirjam S., additional, Bleeker, Jaco C., additional, van Duinen, Sjoerd G., additional, Jager, Martine J., additional, Creutzberg, Carien L., additional, and Luyten, Gregorius P. M., additional

Published
2020
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27. Standard fluoropyrimidine dosages in chemoradiation therapy result in an increased risk of severe toxicity in DPYD variant allele carriers

Author

Lunenburg, Carin A T C, Henricks, Linda M, Dreussi, Eva, Peters, Femke P, Fiocco, Marta, Meulendijks, Didier, Toffoli, Giuseppe, Guchelaar, Henk-Jan, Swen, Jesse J, Cecchin, Erika, Schellens, Jan H M, Gelderblom, Hans, Afd Pharmacoepi & Clinical Pharmacology, and Pharmacoepidemiology and Clinical Pharmacology

Subjects
0301 basic medicine, Male, Cancer Research, Radiation-Sensitizing Agents, Databases, Factual, Dihydropyrimidine Dehydrogenase Deficiency, Gastrointestinal Diseases, Gastroenterology, Dihydropyrimidine dehydrogenase deficiency, 0302 clinical medicine, Neoplasms, Medicine, Multicenter Studies as Topic, Aged, 80 and over, Clinical Trials as Topic, Chemoradiotherapy, Middle Aged, Neoplasm Proteins, Oncology, Fluorouracil, 030220 oncology & carcinogenesis, Toxicity, Inactivation, Metabolic, Female, Dihydropyrimidine dehydrogenase, medicine.drug, Adult, medicine.medical_specialty, Antimetabolites, Antineoplastic, Dose, Genotype, 03 medical and health sciences, Young Adult, Internal medicine, Humans, Genetic Predisposition to Disease, Alleles, Capecitabine, Dihydrouracil Dehydrogenase (NADP), Aged, Retrospective Studies, Dose-Response Relationship, Drug, business.industry, medicine.disease, Hematologic Diseases, 030104 developmental biology, Pharmacogenetics, DPYD, business
Abstract

Background Prospective DPYD genotyping prevents severe fluoropyrimidine (FP)-induced toxicity by decreasing dosages in DPYD variant allele carriers. FP dosages in chemoradiation therapy (CRT) are lower than those in other FP-containing regimens. Pharmacogenetic guidelines do not distinguish between regimens, leaving physicians in doubt to apply dose reductions. Our aim was to investigate severe toxicity in DPYD variant allele carriers receiving CRT. Methods Medical records of 828 patients who received FP-based CRT were reviewed from three centres. Severe (grade ≥III) toxicity in DPYD variant allele carriers receiving upfront FP dose reductions according to pharmacogenetic dosing guidelines and DPYD variant allele carriers not receiving FP dose reductions was compared with DPYD wild-type patients receiving standard dose of FPs in CRT. Results DPYD variant allele carriers treated with standard dosages (N = 34) showed an increased risk of severe gastrointestinal (adjusted OR = 2.58, confidence interval [CI] = 1.02–6.53, P = 0.045) or severe haematological (adjusted OR = 4.19, CI = 1.32–13.25, P = 0.015) toxicity compared with wild-type patients (N = 771). DPYD variant allele carriers who received dose reductions (N = 22) showed a comparable frequency of severe gastrointestinal toxicity compared with wild-type patients, but more (not statistically significant) severe haematological toxicity. Hospitalisations for all DPYD variant allele carriers were comparable, independent of dose adjustments; however, the mean duration of hospitalisation was significantly shorter in the dose reduction group (P = 0.010). Conclusions Standard FP dosages in CRT resulted in an increased risk of severe toxicity in DPYD variant allele carriers. We advise to apply FP dose reductions according to current guidelines in DPYD variant allele carriers starting CRT.

Published
2018

28. Standard fluoropyrimidine dosages in chemoradiation therapy result in an increased risk of severe toxicity in DPYD variant allele carriers

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Lunenburg, Carin A T C, Henricks, Linda M, Dreussi, Eva, Peters, Femke P, Fiocco, Marta, Meulendijks, Didier, Toffoli, Giuseppe, Guchelaar, Henk-Jan, Swen, Jesse J, Cecchin, Erika, Schellens, Jan H M, Gelderblom, Hans, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Lunenburg, Carin A T C, Henricks, Linda M, Dreussi, Eva, Peters, Femke P, Fiocco, Marta, Meulendijks, Didier, Toffoli, Giuseppe, Guchelaar, Henk-Jan, Swen, Jesse J, Cecchin, Erika, Schellens, Jan H M, and Gelderblom, Hans

Published
2018

29. Standard fluoropyrimidine dosages in chemoradiation therapy result in an increased risk of severe toxicity in DPYD variant allele carriers

Author

Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, Lunenburg, Carin A T C, Henricks, Linda M, Dreussi, Eva, Peters, Femke P, Fiocco, Marta, Meulendijks, Didier, Toffoli, Giuseppe, Guchelaar, Henk-Jan, Swen, Jesse J, Cecchin, Erika, Schellens, Jan H M, Gelderblom, Hans, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, Lunenburg, Carin A T C, Henricks, Linda M, Dreussi, Eva, Peters, Femke P, Fiocco, Marta, Meulendijks, Didier, Toffoli, Giuseppe, Guchelaar, Henk-Jan, Swen, Jesse J, Cecchin, Erika, Schellens, Jan H M, and Gelderblom, Hans

Published
2018

30. Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo) Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study

Author

Rombouts, Anouk J M, primary, Al-Najami, Issam, additional, Abbott, Natalie L, additional, Appelt, Ane, additional, Baatrup, Gunnar, additional, Bach, Simon, additional, Bhangu, Aneel, additional, Garm Spindler, Karen-Lise, additional, Gray, Richard, additional, Handley, Kelly, additional, Kaur, Manjinder, additional, Kerkhof, Ellen, additional, Kronborg, Camilla Jensenius, additional, Magill, Laura, additional, Marijnen, Corrie A M, additional, Nagtegaal, Iris D, additional, Nyvang, Lars, additional, Peters, Femke P, additional, Pfeiffer, Per, additional, Punt, Cornelis, additional, Quirke, Philip, additional, Sebag-Montefiore, David, additional, Teo, Mark, additional, West, Nick, additional, and de Wilt, Johannes H W, additional

Published
2017
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31. Optimisation of Organ Preservation treatment strategies in patients with rectal cancer with a good clinical response after neoadjuvant (chemo)radiotherapy: Additional contact X-ray brachytherapy versus eXtending the observation period and local excision (OPAXX) - protocol for two multicentre, parallel, single-arm, phase II studies.

Author

Geubels BM, van Triest B, Peters FP, Maas M, Beets GL, Marijnen CAM, Custers PA, Rutten HJT, Theuws JCM, Verrijssen AE, Cnossen JS, Burger JWA, and Grotenhuis BA

Subjects
Humans, Neoadjuvant Therapy, X-Rays, Organ Preservation, Quality of Life, Treatment Outcome, Chemoradiotherapy, Observational Studies as Topic, Multicenter Studies as Topic, Clinical Trials, Phase II as Topic, Brachytherapy, Rectal Neoplasms surgery
Abstract

Introduction: Standard treatment for patients with intermediate or locally advanced rectal cancer is (chemo)radiotherapy followed by total mesorectal excision (TME) surgery. In recent years, organ preservation aiming at improving quality of life has been explored. Patients with a complete clinical response to (chemo)radiotherapy can be managed safely with a watch-and-wait approach. However, the optimal organ-preserving treatment strategy for patients with a good, but not complete clinical response remains unclear. The aim of the OPAXX study is to determine the rate of organ preservation that can be achieved in patients with rectal cancer with a good clinical response after neoadjuvant (chemo)radiotherapy by additional local treatment options., Methods and Analysis: The OPAXX study is a Dutch multicentre study that investigates the efficacy of two additional local treatments aiming at organ preservation in patients with a good, but not complete response to neoadjuvant treatment (ie near-complete response or a small residual tumour mass <3 cm). The sample size will be 168 patients in total. Patients will be randomised (1:1) between two parallel single-arm phase II studies: study arm 1 involves additional contact X-ray brachytherapy (an intraluminal radiation boost), while in study arm 2 the observation period is extended followed by a second response evaluation and optional transanal local excision. The primary endpoint of the study is the rate of successful organ preservation at 1 year following randomisation. Secondary endpoints include toxicity, morbidity, oncological and functional outcomes at 1 and 2 years of follow-up. Finally, an observational cohort study for patients who are not eligible for randomisation is conducted., Ethics and Dissemination: The trial protocol has been approved by the medical ethics committee of the Netherlands Cancer Institute (METC20.1276/M20PAX). Informed consent will be obtained from all participants. The trial results will be published in an international peer-reviewed journal., Trial Registration Number: NCT05772923., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2023
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32. Can we S ave the rectum by watchful waiting or T rans A nal microsurgery following (chemo) R adiotherapy versus T otal mesorectal excision for early RE ctal C ancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study.

Author

Rombouts AJM, Al-Najami I, Abbott NL, Appelt A, Baatrup G, Bach S, Bhangu A, Garm Spindler KL, Gray R, Handley K, Kaur M, Kerkhof E, Kronborg CJ, Magill L, Marijnen CAM, Nagtegaal ID, Nyvang L, Peters FP, Pfeiffer P, Punt C, Quirke P, Sebag-Montefiore D, Teo M, West N, and de Wilt JHW

Subjects
Adenocarcinoma pathology, Europe, Feasibility Studies, Humans, Microsurgery methods, Rectal Neoplasms pathology, Rectum pathology, Regression Analysis, Research Design, Treatment Outcome, Watchful Waiting, Adenocarcinoma therapy, Chemoradiotherapy methods, Digestive System Surgical Procedures methods, Organ Sparing Treatments, Rectal Neoplasms therapy, Rectum surgery
Abstract

Introduction: Total mesorectal excision (TME) is the highly effective standard treatment for rectal cancer but is associated with significant morbidity and may be overtreatment for low-risk cancers. This study is designed to determine the feasibility of international recruitment in a study comparing organ-saving approaches versus standard TME surgery., Methods and Analysis: STAR-TREC trial is a multicentre international randomised, three-arm parallel, phase II feasibility study in patients with biopsy-proven adenocarcinoma of the rectum. The trial is coordinated from Birmingham, UK with national hubs in Radboudumc (the Netherlands) and Odense University Hospital Svendborg UMC (Denmark). Patients with rectal cancer, staged by CT and MRI as ≤cT3b (up to 5 mm of extramural spread) N0 M0 can be included. Patients will be randomised to either standard TME surgery (control), organ-saving treatment using long-course concurrent chemoradiation or organ-saving treatment using short-course radiotherapy. For patients treated with an organ-saving strategy, clinical response to (chemo)radiotherapy determines the next treatment step. An active surveillance regime will be performed in the case of a complete clinical regression. In the case of incomplete clinical regression, patients will proceed to local excision using an optimised platform such as transanal endoscopic microsurgery or other transanal techniques (eg, transanal endoscopic operation or transanal minimally invasive surgery). The primary endpoint of this phase II study is to demonstrate sufficient international recruitment in order to sustain a phase III study incorporating pelvic failure as the primary endpoint. Success in phase II is defined as randomisation of at least four cases per month internationally in year 1, rising to at least six cases per month internationally during year 2., Ethics and Dissemination: The medical ethical committees of all the participating countries have approved the study protocol. Results of the primary and secondary endpoints will be submitted for publication in peer-reviewed journals., Trial Registration Number: ISRCTN14240288, 20 October 2016. NCT02945566; Pre-results, October 2016., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Published
2017
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