Authorised Therapeutic exploratory (Phase II) Irresectable peritoneal metastases of colorectal cancer

Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases – a phase II study

EU CTIS ID: 2024-517152-34-00

What this study is testing

The main objective is to explore the anti-tumor activity (defined as overall survival) of the addition of intraperitoneal irinotecan (75 mg) to mFOLFOX4 / Bevacizumab in patients with unresectable colorectal peritoneal metastases.

  • Therapeutic exploratory (Phase II)

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

  • Histologically confirmed colorectal cancer; - Radiologically and clinically or pathologically confirmed unresectable colorectal peritoneal metastases (e.g. PCI >20, extensive small bowel involvement, unresectable disease due to anatomical location); - WHO performance score of 0-1 with a life expectancy of >3 months; - Aged 18 years or older; - Written informed consent.

You likely can't join if

  • Presence of extensive systemic metastases that are deemed to be the dominant factor determining prognosis in terms of life expectancy and performance status [e.g. no imminent threat of impaired organ functioning due to the presence of systemic metastases]); - Prior cytoreductive surgery; - Prior palliative systemic therapy for colorectal cancer; - Prior neo-adjuvant/adjuvant systemic therapy for colorectal cancer within the last 6 months; - Homozygous UGT1A1*28 genotype; - Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency - Microsatellite instable (MSI) primary tumor - Inadequate organ functions, defined as an haemoglobin of <5 mmol/L, an absolute neutrophil count of <1.5 x 109/L, platelet count of <100 x 109/L, serum creatinine of >1.5 x ULN, creatinine clearance of <30 ml/min, Bilirubin > 2x ULN and liver transaminases of >5 x ULN.

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.