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)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512318-16-00

Acronym

2024-512318-16-00

Enrollment

Registered

2024-10-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with colorectal peritoneal metastases with a PCI-score of 1-20

Brief summary

The number of patients that is able to undergo all trial treatments (minimally 4 cycles of IP and systemic chemotherapy, followed by CRS-HIPEC)

Detailed description

Measured toxicity in patients during trial treatments (measured by the amount of AE/SAE and SUSAR), Pathological response after trial treatment (assessed by the MANDARD scoring system and the Tumor Regression Grading System), Radiologic response measured by RECIST and PERCIST (ceCT vs. PET/CT), Comparison of PCI-scores of the diagnostic laparoscopy, CRS-HIPEC, PET-CT and CT, Quality of life assessment via EQ-5D-5L, QLQ-C30, QLQ-CR29, iMTA productivity cost questionnaire (PCQ), and iMTA medical consumption questionnaire (MCQ) at selected points during the trial, Disease free survival, after CRS-HIPEC, with a follow-up of 6 months

Interventions

DRUGCalcium Folinate 10 mg/ml Solution for injection or infusion

DRUGIrinotecanhydrochloridetrihydraat Hikma 20 mg/ml

DRUGconcentraat voor oplossing voor infusie

DRUGFluorouracil Accord 50 mg/ml

DRUGoplossing voor injectie of infusie

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

DRUGOxaliplatin Eugia 5 mg/ml concentraat voor oplossing voor infusie

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The number of patients that is able to undergo all trial treatments (minimally 4 cycles of IP and systemic chemotherapy, followed by CRS-HIPEC)	—

Secondary

Measure	Time frame
Measured toxicity in patients during trial treatments (measured by the amount of AE/SAE and SUSAR), Pathological response after trial treatment (assessed by the MANDARD scoring system and the Tumor Regression Grading System), Radiologic response measured by RECIST and PERCIST (ceCT vs. PET/CT), Comparison of PCI-scores of the diagnostic laparoscopy, CRS-HIPEC, PET-CT and CT, Quality of life assessment via EQ-5D-5L, QLQ-C30, QLQ-CR29, iMTA productivity cost questionnaire (PCQ), and iMTA medical consumption questionnaire (MCQ) at selected points during the trial, Disease free survival, after CRS-HIPEC, with a follow-up of 6 months	—

Measure

Time frame

—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026