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Neo-adjuvant intraperitoneal chemotherapy (irinotecan) and systemic chemotherapy (mFOLFOX4-bevacizumab) prior to CRS-HIPEC for patients with isolated resectable colorectal peritoneal metastases: a multicentre, phase II trial (INTERACT-PLUS)
EU CTIS ID: 2024-512318-16-00
What this study is testing
Is treatment, of patients with peritoneal metastases from colorectal origin, of intravenous mFOLFOX4-bevacizumab and intraperitoneal irinotecan (75mg), followed by two cycles of intravenous mFOLFOX4 and intraperitoneal irinotecan) feasible prior to receiving a CRS-HIPEC procedure?
- 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 CRC (colorectal carcinoma)
- Pathologically or radiologically & clinically confirmed, non-appendiceal, adenocarcinoma with PM (peritoneal metastases)
- Synchronous or metachronous PM
- Macroscopic PM still present at time of inclusion/at diagnostic laparoscopy
- Surgical PCI (peritoneal cancer index) score 1 to, or equal to 20 (macroscopic disease)
- No systemic metastases, at enrolment
You likely can't join if
- Prior cytoreductive surgery and/or HIPEC
- Inadequate organ functions (defined as a haemoglobin <5mmol/l, an absolute neutrophil count <1.5 x 109/l, platelet count <100 x 109/l, serum creatinine >1.5 x ULN, creatinine clearance <30ml/min, bilirubin >2x ULN and liver transaminases >2.5x ULN)
- Major cardiovascular events
- Severe diarrhoea
- Severe stomatitis/ulceration in the mouth or GI-tract
- Unstable or uncompensated respiratory and/or cardiac disease
See the full eligibility criteria
- Histologically confirmed CRC (colorectal carcinoma)
- Pathologically or radiologically & clinically confirmed, non-appendiceal, adenocarcinoma with PM (peritoneal metastases)
- Synchronous or metachronous PM
- Macroscopic PM still present at time of inclusion/at diagnostic laparoscopy
- Surgical PCI (peritoneal cancer index) score 1 to, or equal to 20 (macroscopic disease)
- No systemic metastases, at enrolment
- WHO-performance score of 0 to 1 with a life expectancy greater than or equal to three months
- Aged above 18 years old
- Written informed consent
- Prior cytoreductive surgery and/or HIPEC
- Inadequate organ functions (defined as a haemoglobin <5mmol/l, an absolute neutrophil count <1.5 x 109/l, platelet count <100 x 109/l, serum creatinine >1.5 x ULN, creatinine clearance <30ml/min, bilirubin >2x ULN and liver transaminases >2.5x ULN)
- Major cardiovascular events
- Severe diarrhoea
- Severe stomatitis/ulceration in the mouth or GI-tract
- Unstable or uncompensated respiratory and/or cardiac disease
- Bleeding diathesis or coagulopathy
- Pregnancy or lactation
- Prior systemic therapy for CRC within the six months before enrolment in this study
- Contra-indications for CRS-HIPEC; contrast administration (allergy)
- Signet cell carcinoma
- Multi drug resistant (MDR) tumors
- Microsatellite instable (MSI) tumour
- Homozygous UGT1A1*28 genotype
- Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency
- Any contra-indication for the (planned) chemotherapy (e.g. active infection, serious concomitant disease, severe allergy, …), as determined by the medical oncologist
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.
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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.