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)
Key facts
- Where
- Amsterdam, Eindhoven és Rotterdam, HollandiaSee the 4 sites
- Phase
- 2. fázis
Where in Hollandia
- Netherlands Cancer InstituteAmsterdam, HollandiaToborzás még nem indult
- Stichting Amsterdam UMCAmsterdam, HollandiaToborzás még nem indult
- Catharina Ziekenhuis StichtingEindhoven, HollandiaToborzás még nem indult
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Trial code
- EU 2024-512318-16-00
- Record updated
- 2026. január 2.
- Original description
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?Read full original descriptionShow less
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?
Inclusion: 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.
Exclusion: 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; Unstable or uncompensated respiratory and/or cardiac disease; Bleeding diathesis or coagulopathy; Contra-indications for CRS-HIPEC; contrast administration (allergy); 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; Pregnancy or lactation; Signet cell carcinoma; Microsatellite instable (MSI) tumour; Homozygous UGT1A1*28 genotype; Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency.