2024-512318-16-00Not yet recruitingPhase 2
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 2 Jan 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 3 Jul 2024
- Start date
- 1 Oct 2024
- Lead sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Diseases
- Colorectal cancer
- EU CT number
- 2024-512318-16-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with colorectal cancer that has spread to the lining of the abdomen (peritoneum) and nowhere else. The cancer must be visible and mild to moderate in extent (PCI score 1 to 20).
- Age
- Above 18 years old
- Sex
- All sexes can join.
- Disease stage
- Colorectal adenocarcinoma (not from the appendix) with peritoneal metastases, seen at surgery, with a PCI score of 1 to 20. No metastases elsewhere in the body.
- Earlier treatment
- No earlier cytoreductive surgery or HIPEC. No systemic therapy for colorectal cancer in the six months before enrolment.
- Biomarker or test result
- Tumours with microsatellite instability (MSI), the UGT1A1*28 genotype on both gene copies, or complete DPD deficiency on both gene copies cannot join.
Main reasons for not taking part
- Signet cell carcinoma or multi drug resistant tumour
- Poor blood counts, kidney function or liver function
- Major heart events, unstable heart or lung disease, bleeding or clotting disorder
- Severe diarrhoea or severe mouth or gut sores
- Pregnancy or breastfeeding
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior cytoreductive surgery and/or HIPEC
- Prior systemic therapy for CRC within the six months before enrolment in this study
- Multi drug resistant (MDR) tumors
- Any contra-indication for the (planned) chemotherapy (e.g. active infection, serious concomitant disease, severe allergy, …), as determined by the medical oncologist
Other illness
- Unstable or uncompensated respiratory and/or cardiac disease
- Bleeding diathesis or coagulopathy
- Contra-indications for CRS-HIPEC; contrast administration (allergy)
Lab values
- 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)
Other
- Major cardiovascular events
- Severe diarrhoea
- Severe stomatitis/ulceration in the mouth or GI-tract
- Pregnancy or lactation
- Signet cell carcinoma
- Microsatellite instable (MSI) tumour
- Homozygous UGT1A1*28 genotype
- Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Netherlands Cancer Institute | Amsterdam | Netherlands | Not yet recruiting |
| Stichting Amsterdam UMC | Amsterdam | Netherlands | Not yet recruiting |
| Catharina Ziekenhuis Stichting | Eindhoven | Netherlands | Not yet recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.