Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases

Phase 2

Active, not recruiting

• Conditions: Colorectal Neoplasm; Colorectal Cancer; Colorectal Neoplasms Malignant; Colorectal Carcinoma; Colorectal Adenocarcinoma; Peritoneal Neoplasms; Peritoneal Carcinomatosis; Peritoneal Cancer; Peritoneal Metastases; Peritoneal Neoplasm Malignant Secondary Carcinomatosis

• Registration Number: NCT02758951
• Lead Sponsor: Koen Rovers

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-4-26
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

Eligible patients are adults who have:<br><br> - a World Health Organisation (WHO) performance status of =1;<br><br> - histological or cytological proof of PM of a non-appendiceal colorectal<br> adenocarcinoma with =50% of the tumour cells being signet ring cells;<br><br> - resectable disease determined by abdominal computed tomography (CT) and a diagnostic<br> laparoscopy/laparotomy;<br><br> - no evidence of systemic colorectal metastases within three months prior to<br> enrolment;<br><br> - no systemic therapy for colorectal cancer within six months prior to enrolment;<br><br> - no contraindications for CRS-HIPEC;<br><br> - no previous CRS-HIPEC;<br><br> - no concurrent malignancies that interfere with the planned study treatment or the<br> prognosis of resected colorectal PM.<br><br>Importantly, enrolment is allowed for patients with radiologically non-measurable<br>disease. The diagnostic laparoscopy/laparotomy may be performed in a referring centre,<br>provided that the peritoneal cancer index (PCI) is appropriately scored and documented<br>before enrolment.<br><br>Patients are excluded in case of any comorbidity or condition that prevents safe<br>administration of the planned perioperative systemic therapy, determined by the treating<br>medical oncologist, e.g.:<br><br> - Inadequate bone marrow, renal, or liver functions (e.g. haemoglobin <6.0 mmol/L,<br> neutrophils <1.5 x 109/L, platelets <100 x 109/L, serum creatinine >1.5 x ULN,<br> creatinine clearance <30 ml/min, bilirubin >2 x ULN, serum liver transaminases >5 x<br> ULN);<br><br> - Previous intolerance of fluoropyrimidines or both oxaliplatin and irinotecan;<br><br> - Dehydropyrimidine dehydrogenase deficiency;<br><br> - Serious active infections;<br><br> - Severe diarrhoea;<br><br> - Stomatitis or ulceration in the mouth or gastrointestinal tract;<br><br> - Recent major cardiovascular events;<br><br> - Unstable or uncompensated respiratory or cardiac disease;<br><br> - Bleeding diathesis or coagulopathy;<br><br> - Pregnancy or lactation.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified