Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone for isolated resectable colorectal peritoneal metastases: protocol of a multicentre, open-label, parallel-group, phase II-III, randomised, superiority study (CAIRO6)
Abstract Background Upfront cytoreductive surgery with HIPEC (CRS-HIPEC) is the standard treatment for isolated resectable colorectal peritoneal metastases (PM) in the Netherlands. This study investigates whether addition of perioperative systemic therapy to CRS-HIPEC improves oncological outcomes....
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2019-04-01
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| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12885-019-5545-0 |
| _version_ | 1828771847051673600 |
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| author | Koen P. Rovers Checca Bakkers Geert A. A. M. Simkens Jacobus W. A. Burger Simon W. Nienhuijs Geert-Jan M. Creemers Anna M. J. Thijs Alexandra R. M. Brandt-Kerkhof Eva V. E. Madsen Ninos Ayez Nadine L. de Boer Esther van Meerten Jurriaan B. Tuynman Miranda Kusters Nina R. Sluiter Henk M. W. Verheul Hans J. van der Vliet Marinus J. Wiezer Djamila Boerma Emma C. E. Wassenaar Maartje Los Cornelis B. Hunting Arend G. J. Aalbers Niels F. M. Kok Koert F. D. Kuhlmann Henk Boot Myriam Chalabi Schelto Kruijff Lukas B. Been Robert J. van Ginkel Derk Jan A. de Groot Rudolf S. N. Fehrmann Johannes H. W. de Wilt Andreas J. A. Bremers Philip R. de Reuver Sandra A. Radema Karin H. Herbschleb Wilhelmina M. U. van Grevenstein Arjen J. Witkamp Miriam Koopman Nadia Haj Mohammad Eino B. van Duyn Walter J. B. Mastboom Leonie J. M. Mekenkamp Joost Nederend Max J. Lahaye Petur Snaebjornsson Cornelis Verhoef Hanneke W. M. van Laarhoven Aeilko H. Zwinderman Jeanette M. Bouma Onno Kranenburg Iris van ‘t Erve Remond J. A. Fijneman Marcel G. W. Dijkgraaf Patrick H. J. Hemmer Cornelis J. A. Punt Pieter J. Tanis Ignace H. J. T. de Hingh Dutch Peritoneal Oncology Group (DPOG) Dutch Colorectal Cancer Group (DCCG) |
| author_facet | Koen P. Rovers Checca Bakkers Geert A. A. M. Simkens Jacobus W. A. Burger Simon W. Nienhuijs Geert-Jan M. Creemers Anna M. J. Thijs Alexandra R. M. Brandt-Kerkhof Eva V. E. Madsen Ninos Ayez Nadine L. de Boer Esther van Meerten Jurriaan B. Tuynman Miranda Kusters Nina R. Sluiter Henk M. W. Verheul Hans J. van der Vliet Marinus J. Wiezer Djamila Boerma Emma C. E. Wassenaar Maartje Los Cornelis B. Hunting Arend G. J. Aalbers Niels F. M. Kok Koert F. D. Kuhlmann Henk Boot Myriam Chalabi Schelto Kruijff Lukas B. Been Robert J. van Ginkel Derk Jan A. de Groot Rudolf S. N. Fehrmann Johannes H. W. de Wilt Andreas J. A. Bremers Philip R. de Reuver Sandra A. Radema Karin H. Herbschleb Wilhelmina M. U. van Grevenstein Arjen J. Witkamp Miriam Koopman Nadia Haj Mohammad Eino B. van Duyn Walter J. B. Mastboom Leonie J. M. Mekenkamp Joost Nederend Max J. Lahaye Petur Snaebjornsson Cornelis Verhoef Hanneke W. M. van Laarhoven Aeilko H. Zwinderman Jeanette M. Bouma Onno Kranenburg Iris van ‘t Erve Remond J. A. Fijneman Marcel G. W. Dijkgraaf Patrick H. J. Hemmer Cornelis J. A. Punt Pieter J. Tanis Ignace H. J. T. de Hingh Dutch Peritoneal Oncology Group (DPOG) Dutch Colorectal Cancer Group (DCCG) |
| author_sort | Koen P. Rovers |
| collection | DOAJ |
| description | Abstract Background Upfront cytoreductive surgery with HIPEC (CRS-HIPEC) is the standard treatment for isolated resectable colorectal peritoneal metastases (PM) in the Netherlands. This study investigates whether addition of perioperative systemic therapy to CRS-HIPEC improves oncological outcomes. Methods This open-label, parallel-group, phase II-III, randomised, superiority study is performed in nine Dutch tertiary referral centres. Eligible patients are adults who have a good performance status, histologically or cytologically proven resectable PM of a colorectal adenocarcinoma, no systemic colorectal metastases, no systemic therapy for colorectal cancer within six months prior to enrolment, and no previous CRS-HIPEC. Eligible patients are randomised (1:1) to perioperative systemic therapy and CRS-HIPEC (experimental arm) or upfront CRS-HIPEC alone (control arm) by using central randomisation software with minimisation stratified by a peritoneal cancer index of 0–10 or 11–20, metachronous or synchronous PM, previous systemic therapy for colorectal cancer, and HIPEC with oxaliplatin or mitomycin C. At the treating physician’s discretion, perioperative systemic therapy consists of either four 3-weekly neoadjuvant and adjuvant cycles of capecitabine with oxaliplatin (CAPOX), six 2-weekly neoadjuvant and adjuvant cycles of 5-fluorouracil/leucovorin with oxaliplatin (FOLFOX), or six 2-weekly neoadjuvant cycles of 5-fluorouracil/leucovorin with irinotecan (FOLFIRI) followed by four 3-weekly (capecitabine) or six 2-weekly (5-fluorouracil/leucovorin) adjuvant cycles of fluoropyrimidine monotherapy. Bevacizumab is added to the first three (CAPOX) or four (FOLFOX/FOLFIRI) neoadjuvant cycles. The first 80 patients are enrolled in a phase II study to explore the feasibility of accrual and the feasibility, safety, and tolerance of perioperative systemic therapy. If predefined criteria of feasibility and safety are met, the study continues as a phase III study with 3-year overall survival as primary endpoint. A total of 358 patients is needed to detect the hypothesised 15% increase in 3-year overall survival (control arm 50%; experimental arm 65%). Secondary endpoints are surgical characteristics, major postoperative morbidity, progression-free survival, disease-free survival, health-related quality of life, costs, major systemic therapy related toxicity, and objective radiological and histopathological response rates. Discussion This is the first randomised study that prospectively compares oncological outcomes of perioperative systemic therapy and CRS-HIPEC with upfront CRS-HIPEC alone for isolated resectable colorectal PM. Trial registration Clinicaltrials.gov/NCT02758951, NTR/NTR6301, ISRCTN/ISRCTN15977568, EudraCT/2016–001865-99. |
| first_indexed | 2024-12-11T14:33:06Z |
| format | Article |
| id | doaj.art-0eae7e00e09f44039f07a47639a0e680 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-11T14:33:06Z |
| publishDate | 2019-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-0eae7e00e09f44039f07a47639a0e6802022-12-22T01:02:19ZengBMCBMC Cancer1471-24072019-04-0119111510.1186/s12885-019-5545-0Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone for isolated resectable colorectal peritoneal metastases: protocol of a multicentre, open-label, parallel-group, phase II-III, randomised, superiority study (CAIRO6)Koen P. Rovers0Checca Bakkers1Geert A. A. M. Simkens2Jacobus W. A. Burger3Simon W. Nienhuijs4Geert-Jan M. Creemers5Anna M. J. Thijs6Alexandra R. M. Brandt-Kerkhof7Eva V. E. Madsen8Ninos Ayez9Nadine L. de Boer10Esther van Meerten11Jurriaan B. Tuynman12Miranda Kusters13Nina R. Sluiter14Henk M. W. Verheul15Hans J. van der Vliet16Marinus J. Wiezer17Djamila Boerma18Emma C. E. Wassenaar19Maartje Los20Cornelis B. Hunting21Arend G. J. Aalbers22Niels F. M. Kok23Koert F. D. Kuhlmann24Henk Boot25Myriam Chalabi26Schelto Kruijff27Lukas B. Been28Robert J. van Ginkel29Derk Jan A. de Groot30Rudolf S. N. Fehrmann31Johannes H. W. de Wilt32Andreas J. A. Bremers33Philip R. de Reuver34Sandra A. Radema35Karin H. Herbschleb36Wilhelmina M. U. van Grevenstein37Arjen J. Witkamp38Miriam Koopman39Nadia Haj Mohammad40Eino B. van Duyn41Walter J. B. Mastboom42Leonie J. M. Mekenkamp43Joost Nederend44Max J. Lahaye45Petur Snaebjornsson46Cornelis Verhoef47Hanneke W. M. van Laarhoven48Aeilko H. Zwinderman49Jeanette M. Bouma50Onno Kranenburg51Iris van ‘t Erve52Remond J. A. Fijneman53Marcel G. W. Dijkgraaf54Patrick H. J. Hemmer55Cornelis J. A. Punt56Pieter J. Tanis57Ignace H. J. T. de Hingh58Dutch Peritoneal Oncology Group (DPOG)Dutch Colorectal Cancer Group (DCCG)Department of Surgery, Catharina HospitalDepartment of Surgery, Catharina HospitalDepartment of Surgery, Catharina HospitalDepartment of Surgery, Catharina HospitalDepartment of Surgery, Catharina HospitalDepartment of Medical Oncology, Catharina HospitalDepartment of Medical Oncology, Catharina HospitalDepartment of Surgical Oncology, Erasmus Medical CentreDepartment of Surgical Oncology, Erasmus Medical CentreDepartment of Surgical Oncology, Erasmus Medical CentreDepartment of Surgical Oncology, Erasmus Medical CentreDepartment of Medical Oncology, Erasmus MC Cancer InstituteDepartment of Surgery, Amsterdam University Medical CentresDepartment of Surgery, Amsterdam University Medical CentresDepartment of Surgery, Amsterdam University Medical CentresDepartment of Medical Oncology, Amsterdam University Medical CentresDepartment of Medical Oncology, Amsterdam University Medical CentresDepartment of Surgery, St. Antonius HospitalDepartment of Surgery, St. Antonius HospitalDepartment of Surgery, St. Antonius HospitalDepartment of Medical Oncology, St. Antonius HospitalDepartment of Medical Oncology, St. Antonius HospitalDepartment of Surgical Oncology, Netherlands Cancer InstituteDepartment of Surgical Oncology, Netherlands Cancer InstituteDepartment of Surgical Oncology, Netherlands Cancer InstituteDepartment of Gastrointestinal Oncology, Netherlands Cancer InstituteDepartment of Gastrointestinal Oncology, Netherlands Cancer InstituteDepartment of Surgery, University Medical Centre GroningenDepartment of Surgery, University Medical Centre GroningenDepartment of Surgery, University Medical Centre GroningenDepartment of Medical Oncology, University Medical Centre GroningenDepartment of Medical Oncology, University Medical Centre GroningenDepartment of Surgery, Radboud University Medical CentreDepartment of Surgery, Radboud University Medical CentreDepartment of Surgery, Radboud University Medical CentreDepartment of Medical Oncology, Radboud University Medical CentreDepartment of Medical Oncology, Radboud University Medical CentreDepartment of Surgery, University Medical Centre UtrechtDepartment of Surgery, University Medical Centre UtrechtDepartment of Medical Oncology, University Medical Centre UtrechtDepartment of Medical Oncology, University Medical Centre UtrechtDepartment of Surgery, Medisch Spectrum TwenteDepartment of Surgery, Medisch Spectrum TwenteDepartment of Medical Oncology, Medisch Spectrum TwenteDepartment of Radiology, Catharina HospitalDepartment of Radiology, Netherlands Cancer InstituteDepartment of Pathology, Netherlands Cancer InstituteDepartment of Surgical Oncology, Erasmus Medical CentreDepartment of Medical Oncology, Amsterdam University Medical CentresDepartment of Clinical Epidemiology, Biostatistics & Bioinformatics, Amsterdam University Medical CentresClinical Trial Department, Netherlands Comprehensive Cancer Organisation (IKNL)UMC Utrecht Cancer Centre, University Medical Centre UtrechtDepartment of Pathology, Netherlands Cancer InstituteDepartment of Pathology, Netherlands Cancer InstituteDepartment of Clinical Epidemiology, Biostatistics & Bioinformatics, Amsterdam University Medical CentresDepartment of Surgery, University Medical Centre GroningenDepartment of Medical Oncology, Amsterdam University Medical CentresDepartment of Surgery, Amsterdam University Medical CentresDepartment of Surgery, Catharina HospitalAbstract Background Upfront cytoreductive surgery with HIPEC (CRS-HIPEC) is the standard treatment for isolated resectable colorectal peritoneal metastases (PM) in the Netherlands. This study investigates whether addition of perioperative systemic therapy to CRS-HIPEC improves oncological outcomes. Methods This open-label, parallel-group, phase II-III, randomised, superiority study is performed in nine Dutch tertiary referral centres. Eligible patients are adults who have a good performance status, histologically or cytologically proven resectable PM of a colorectal adenocarcinoma, no systemic colorectal metastases, no systemic therapy for colorectal cancer within six months prior to enrolment, and no previous CRS-HIPEC. Eligible patients are randomised (1:1) to perioperative systemic therapy and CRS-HIPEC (experimental arm) or upfront CRS-HIPEC alone (control arm) by using central randomisation software with minimisation stratified by a peritoneal cancer index of 0–10 or 11–20, metachronous or synchronous PM, previous systemic therapy for colorectal cancer, and HIPEC with oxaliplatin or mitomycin C. At the treating physician’s discretion, perioperative systemic therapy consists of either four 3-weekly neoadjuvant and adjuvant cycles of capecitabine with oxaliplatin (CAPOX), six 2-weekly neoadjuvant and adjuvant cycles of 5-fluorouracil/leucovorin with oxaliplatin (FOLFOX), or six 2-weekly neoadjuvant cycles of 5-fluorouracil/leucovorin with irinotecan (FOLFIRI) followed by four 3-weekly (capecitabine) or six 2-weekly (5-fluorouracil/leucovorin) adjuvant cycles of fluoropyrimidine monotherapy. Bevacizumab is added to the first three (CAPOX) or four (FOLFOX/FOLFIRI) neoadjuvant cycles. The first 80 patients are enrolled in a phase II study to explore the feasibility of accrual and the feasibility, safety, and tolerance of perioperative systemic therapy. If predefined criteria of feasibility and safety are met, the study continues as a phase III study with 3-year overall survival as primary endpoint. A total of 358 patients is needed to detect the hypothesised 15% increase in 3-year overall survival (control arm 50%; experimental arm 65%). Secondary endpoints are surgical characteristics, major postoperative morbidity, progression-free survival, disease-free survival, health-related quality of life, costs, major systemic therapy related toxicity, and objective radiological and histopathological response rates. Discussion This is the first randomised study that prospectively compares oncological outcomes of perioperative systemic therapy and CRS-HIPEC with upfront CRS-HIPEC alone for isolated resectable colorectal PM. Trial registration Clinicaltrials.gov/NCT02758951, NTR/NTR6301, ISRCTN/ISRCTN15977568, EudraCT/2016–001865-99.http://link.springer.com/article/10.1186/s12885-019-5545-0Colorectal neoplasmsPeritoneal neoplasmsCytoreduction surgical proceduresHyperthermia, inducedNeoadjuvant therapyAdjuvant chemotherapy |
| spellingShingle | Koen P. Rovers Checca Bakkers Geert A. A. M. Simkens Jacobus W. A. Burger Simon W. Nienhuijs Geert-Jan M. Creemers Anna M. J. Thijs Alexandra R. M. Brandt-Kerkhof Eva V. E. Madsen Ninos Ayez Nadine L. de Boer Esther van Meerten Jurriaan B. Tuynman Miranda Kusters Nina R. Sluiter Henk M. W. Verheul Hans J. van der Vliet Marinus J. Wiezer Djamila Boerma Emma C. E. Wassenaar Maartje Los Cornelis B. Hunting Arend G. J. Aalbers Niels F. M. Kok Koert F. D. Kuhlmann Henk Boot Myriam Chalabi Schelto Kruijff Lukas B. Been Robert J. van Ginkel Derk Jan A. de Groot Rudolf S. N. Fehrmann Johannes H. W. de Wilt Andreas J. A. Bremers Philip R. de Reuver Sandra A. Radema Karin H. Herbschleb Wilhelmina M. U. van Grevenstein Arjen J. Witkamp Miriam Koopman Nadia Haj Mohammad Eino B. van Duyn Walter J. B. Mastboom Leonie J. M. Mekenkamp Joost Nederend Max J. Lahaye Petur Snaebjornsson Cornelis Verhoef Hanneke W. M. van Laarhoven Aeilko H. Zwinderman Jeanette M. Bouma Onno Kranenburg Iris van ‘t Erve Remond J. A. Fijneman Marcel G. W. Dijkgraaf Patrick H. J. Hemmer Cornelis J. A. Punt Pieter J. Tanis Ignace H. J. T. de Hingh Dutch Peritoneal Oncology Group (DPOG) Dutch Colorectal Cancer Group (DCCG) Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone for isolated resectable colorectal peritoneal metastases: protocol of a multicentre, open-label, parallel-group, phase II-III, randomised, superiority study (CAIRO6) BMC Cancer Colorectal neoplasms Peritoneal neoplasms Cytoreduction surgical procedures Hyperthermia, induced Neoadjuvant therapy Adjuvant chemotherapy |
| title | Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone for isolated resectable colorectal peritoneal metastases: protocol of a multicentre, open-label, parallel-group, phase II-III, randomised, superiority study (CAIRO6) |
| title_full | Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone for isolated resectable colorectal peritoneal metastases: protocol of a multicentre, open-label, parallel-group, phase II-III, randomised, superiority study (CAIRO6) |
| title_fullStr | Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone for isolated resectable colorectal peritoneal metastases: protocol of a multicentre, open-label, parallel-group, phase II-III, randomised, superiority study (CAIRO6) |
| title_full_unstemmed | Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone for isolated resectable colorectal peritoneal metastases: protocol of a multicentre, open-label, parallel-group, phase II-III, randomised, superiority study (CAIRO6) |
| title_short | Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone for isolated resectable colorectal peritoneal metastases: protocol of a multicentre, open-label, parallel-group, phase II-III, randomised, superiority study (CAIRO6) |
| title_sort | perioperative systemic therapy and cytoreductive surgery with hipec versus upfront cytoreductive surgery with hipec alone for isolated resectable colorectal peritoneal metastases protocol of a multicentre open label parallel group phase ii iii randomised superiority study cairo6 |
| topic | Colorectal neoplasms Peritoneal neoplasms Cytoreduction surgical procedures Hyperthermia, induced Neoadjuvant therapy Adjuvant chemotherapy |
| url | http://link.springer.com/article/10.1186/s12885-019-5545-0 |
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perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT leoniejmmekenkamp perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT joostnederend perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT maxjlahaye perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT petursnaebjornsson perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT cornelisverhoef perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT hannekewmvanlaarhoven perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT aeilkohzwinderman perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT jeanettembouma perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT onnokranenburg perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT irisvanterve perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT remondjafijneman perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT marcelgwdijkgraaf perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT patrickhjhemmer perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT cornelisjapunt perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT pieterjtanis perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT ignacehjtdehingh perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT dutchperitonealoncologygroupdpog perioperativesystemictherapyandcytoreductivesurgerywithhipecversusupfrontcytoreductivesurgerywithhipecaloneforisolatedresectablecolorectalperitonealmetastasesprotocolofamulticentreopenlabelparallelgroupphaseiiiiirandomisedsuperioritystudycairo6 AT dutchcolorectalcancergroupdccg 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