Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver

Recruiting Phase 3 Interventional Study
Colorectal Neoplasms
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
348 (estimated)
Sponsor
Federation Francophone de Cancerologie Digestive · Other
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About This Trial
Colorectal cancer is the 3rd most common cancer in France and the 2nd cause of death from cancer. Between 30 to 60% of patients develop limited or predominant liver metastases. Surgical resection of these metastases, only curative treatment is not immediately possible in 10-15% of cases. In unresectable patients, current palliative treatments are based on systemic chemotherapy associated or not wi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Histologically proven colorectal adenocarcinoma with hepatic metastasis(es) * At least one measurable hepatic metastasis according to the criteria RECIST v1.1 * No other metastatic sites except lung nodules if number ≤ 3 and \< 10 mm * RAS mutation status known (determination …
Contacts

Sofia JOURDAN

+33 (0)380393404

sofia.jourdan@u-bourgogne.fr

CONTACT

Marie MOREAU

+33(0)3 80 39 32 36

marie.moreau@u-bourgogne.fr

CONTACT