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Chemo-immunotherapy before and after surgery for peritoneal metastases of large bowel cancer.
EU CTIS ID: 2024-518570-13-00
What this study is testing
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.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ▪ 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.
You likely can't join if
- ▪ 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.