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IRIMAD Interest of postoperative reintroduction of chemotherapy in patients with colorectal liver metastases who responded well to preoperative chemotherapy with FOLFIRI with or without targeted therapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504831-42-00
Acronym
APHP220917
Enrollment
254
Registered
2024-05-23
Start date
2025-06-27
Completion date
Unknown
Last updated
2025-07-11

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

Conditions

patient with colorectal cancer with hepatic metastasis

Brief summary

Disease-free survival rate at 3 years

Detailed description

Overall survival at 3 years, Liver-free survival at 3 years, Extra -hepatic recurrence rate, Safety including chemotherapy associated toxicity assessed by International Common Terminology Criteria for Adverse Events (CTCAE) grading system, Compliance defined as the ability to administrate a total of 12 cycles of FOLFIRI-based chemotherapy including preoperative treatment, Rate of treatment of recurrence with curative intent

Interventions

DRUGONDANSETRON
DRUGIRINOTECAN
DRUGCALCIUM FOLINATE
DRUGCALCIUM LEVOFOLINATE
DRUGFLUOROURACIL
DRUGMETHYLPREDNISOLONE

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Disease-free survival rate at 3 years

Secondary

MeasureTime frame
Overall survival at 3 years, Liver-free survival at 3 years, Extra -hepatic recurrence rate, Safety including chemotherapy associated toxicity assessed by International Common Terminology Criteria for Adverse Events (CTCAE) grading system, Compliance defined as the ability to administrate a total of 12 cycles of FOLFIRI-based chemotherapy including preoperative treatment, Rate of treatment of recurrence with curative intent

Countries

France

Outcome results

None listed

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