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)

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), 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)

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 .

Keywords: Adjuvant chemotherapy; Bevacizumab; Colorectal neoplasms; Cytoreduction surgical procedures; Hyperthermia, induced; Mortality; Neoadjuvant therapy; Peritoneal neoplasms; Progression-free survival; Randomized controlled trial.

Conflict of interest statement

Ethics approval and consent to participate

This study was approved by a central ethics committee (Medical Research Ethics Committees United, Nieuwegein, Netherlands, R16.056), the Dutch Competent Authority (Centrale Commissie Mensgebonden Onderzoek, The Hague, Netherlands, NL57644.100.16), and the institutional review boards of all study centres. Written informed consent is obtained from all patients participating in this study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
General flowchart of the CAIRO6 study. B blood for translational research; CRS-HIPEC cytoreductive surgery with hyperthermic intraperitoneal chemotherapy; CT thoracoabdominal computed tomography; Q questionnaires (EQ-5D-5L, QLQ-C30, QLQ-CR29, iMTA Productivity Cost Questionnaire, iMTA Medical Consumption Questionnaire); T tissue for translational research
Fig. 2
Fig. 2
Flowchart of the perioperative systemic therapy in the experimental arm. Acapecitabine; B5-fluorouracil, leucovorin; CAPOX capecitabine, oxaliplatin; CAPOX-B capecitabine, oxaliplatin, bevacizumab; CRS-HIPEC cytoreductive surgery with hyperthermic intraperitoneal chemotherapy; CT computed tomography; FOLFIRI 5-fluorouracil, leucovorin, irinotecan; FOLFIRI-B 5-fluorouracil, leucovorin, irinotecan, bevacizumab; FOLFOX 5-fluorouracil, leucovorin, oxaliplatin; FOLFOX-B 5-fluorouracil, leucovorin, oxaliplatin, bevacizumab

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