Adjuvant FOLFIRI Based-chemotherapy After Resection of CLM Responding to Preoperative FOLFIRI

Recruiting Phase 3 Interventional Study
Colorectal Cancer Colorectal Liver Metastases
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
254 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
Eligible patients are patients with contraindication to preoperative oxaliplatin based-chemotherapy who underwent resection of no more than 10 colorectal liver metastases after preoperative FOLFIRI based chemotherapy with or without targeted agents. These patients must have objective response to treatment (radiologic or pathologic response). The standard care for these patients is no postoperative…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Histologically proven resected metachronous CLM with curative intent that could not be treated with perioperative oxaliplatin-based chemotherapy for oncologic or tolerability reasons. For this study, metachronous CLM is defined as liver recurrence occurring more than 12 months…
Contacts

Stéphane BENOIST, MHD, PHD

33 1 45 21 34 72

Stephane.benoist@aphp.fr

CONTACT

Antoine BROUQUET, MHD, PHD

+33 1 45 21 34 70

Anoine.brouquet@aphp.fr

CONTACT