NL-OMON55637
Recruiting
Phase 3
Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone: a multicentre, open-label, parallel-group, phase II-III, randomised superiority study (CAIRO6). - CAIRO6
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Peritoneal metastases of colorectal cancer
- Sponsor
- Catharina-ziekenhuis
- Enrollment
- 298
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
- •\* no systemic therapy for colorectal cancer within six months prior to
- •\* no contraindications for CRS\-HIPEC;
- •\* no previous CRS\-HIPEC;
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Not specified
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