Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases (CAIRO6)
Colorectal Neoplasm, Colorectal Cancer, Colorectal Neoplasms Malignant
About this trial
This is an interventional treatment trial for Colorectal Neoplasm focused on measuring Colorectal Neoplasms, Peritoneal Neoplasms, Cytoreduction Surgical Procedures, Hyperthermia, Induced, Neoadjuvant Therapy, Adjuvant Chemotherapy, Bevacizumab, Randomized Controlled Trial, Mortality, Progression-Free Survival
Eligibility Criteria
Eligible patients are adults who have:
- a World Health Organisation (WHO) performance status of ≤1;
- histological or cytological proof of PM of a non-appendiceal colorectal adenocarcinoma with ≤50% of the tumour cells being signet ring cells;
- resectable disease determined by abdominal computed tomography (CT) and a diagnostic laparoscopy/laparotomy;
- no evidence of systemic colorectal metastases within three months prior to enrolment;
- no systemic therapy for colorectal cancer within six months prior to enrolment;
- no contraindications for CRS-HIPEC;
- no previous CRS-HIPEC;
- no concurrent malignancies that interfere with the planned study treatment or the prognosis of resected colorectal PM.
Importantly, enrolment is allowed for patients with radiologically non-measurable disease. The diagnostic laparoscopy/laparotomy may be performed in a referring centre, provided that the peritoneal cancer index (PCI) is appropriately scored and documented before enrolment.
Patients are excluded in case of any comorbidity or condition that prevents safe administration of the planned perioperative systemic therapy, determined by the treating medical oncologist, e.g.:
- Inadequate bone marrow, renal, or liver functions (e.g. haemoglobin <6.0 mmol/L, neutrophils <1.5 x 109/L, platelets <100 x 109/L, serum creatinine >1.5 x ULN, creatinine clearance <30 ml/min, bilirubin >2 x ULN, serum liver transaminases >5 x ULN);
- Previous intolerance of fluoropyrimidines or both oxaliplatin and irinotecan;
- Dehydropyrimidine dehydrogenase deficiency;
- Serious active infections;
- Severe diarrhoea;
- Stomatitis or ulceration in the mouth or gastrointestinal tract;
- Recent major cardiovascular events;
- Unstable or uncompensated respiratory or cardiac disease;
- Bleeding diathesis or coagulopathy;
- Pregnancy or lactation.
Sites / Locations
- Ziekenhuis Oost-LimburgRecruiting
- Amsterdam University Medical Centre, Location VUMCRecruiting
- Netherlands Cancer InstituteRecruiting
- Catharina HospitalRecruiting
- University Medical Centre GroningenRecruiting
- St. Antonius HospitalRecruiting
- Radboud University Medical CentreRecruiting
- Erasmus University Medical CentreRecruiting
- University Medical Centre UtrechtRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Perioperative systemic therapy and CRS-HIPEC
Upfront CRS-HIPEC alone
At the discretion of the treating physician, 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 either 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. CRS-HIPEC is performed according to the Dutch protocol in all study centres.
CRS-HIPEC is performed according to the Dutch protocol in all study centres.