Chemo-immunotherapy before and after surgery for peritoneal metastases of large bowel cancer.

Phase 2/3

Not yet recruiting

• Conditions: Resectable peritoneal metastases of a colorectal origin

• Registration Number: 2024-518570-13-00
• Lead Sponsor: Catharina Ziekenhuis Stichting

Brief Summary

The primary objectives of the phase II study are to explore the feasibility of accrual, and the feasibility, safety, and tolerance of perioperative systemic therapy.

The primary objective of the phase III study is to compare overall survival between both arms.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-11-12
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 358

Inclusion Criteria

▪ 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 a diagnostic laparoscopy/laparotomy in combination with abdominal computed tomography and/or magnetic resonance imaging (MRI); only in patients in whom diagnostic laparoscopy or laparotomy is considered not feasible or valuable (e.g. due to known adhesions impeding adequate PCI scoring), it is also allowed to determine resectability by CT or MRI only (provided that the colorectal PM are histologically or cytologically proven); ▪ 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.

Exclusion Criteria

▪ 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, to such extent that the oncologist does not consider the patient eligible for systemic therapy; ▪ 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.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the difference between both treatments in terms of overall survival (calculated from the interval from diagnosis of peritoneal metastases until death or last follow-up).		To determine the difference between both treatments in terms of overall survival (calculated from the interval from diagnosis of peritoneal metastases until death or last follow-up).

Trial Locations

Locations (9)

Ziekenhuis Oost Limburg; 🇧🇪 Genk, Belgium

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting; 🇳🇱 Amsterdam, Netherlands

Radboud universitair medisch centrum Stichting; 🇳🇱 Nijmegen, Netherlands

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands

Catharina Ziekenhuis Stichting; 🇳🇱 Eindhoven, Netherlands

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC); 🇳🇱 Rotterdam, Netherlands

Sint Antonius Ziekenhuis Stichting; 🇳🇱 Nieuwegein, Netherlands

Ziekenhuis Oost Limburg

🇧🇪Genk, Belgium

Kurt van der Speeten

Site contact

+3289325050

Kurt.Vanderspeeten@zol.be