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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

Study acronym: OSCAR
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Notable Primary completion date: Sep 2025 to Sep 2028
    • Study sites: 90 to 49
    • Study completion date: Sep 2027 to Sep 2028
    v8
  2. Notable Primary completion date: Sep 2023 to Sep 2025
    • Study completion date: Sep 2025 to Sep 2027
    v7
  3. Notable Primary completion date: Sep 2021 to Sep 2023v6 Show 7 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 268 to 348
    • Study sites: 76 to 90
    • Study completion date: Jun 2023 to Sep 2025
    • Interventions: 5 Fu (Drug), Bevacizumab (Drug), Folinic Acid (Drug), Oxaliplatin intra-arteriel (Drug), Oxaliplatin intravenous (Drug), Panitumumab (Drug) to 5 FU bolus (Drug), 5 FU continuous (Drug), Bevacizumab (Drug), Folinic acid (Drug), Irinotecan (Drug), Oxaliplatin intra-arteriel (Drug)…
    • Study arms: 2 to 4
    • Study title expanded, about 2 words
  4. Notable Primary completion date: Sep 2018 to Sep 2021
    • Study sites: 33 to 76
    v5
  5. Minor Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Study sites: 4 to 33v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2016 to Dec 2016
    • Study sites: 0 to 4
    • Study title revised
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 with the targeted therapies (anti-EGFR (panitumumab), anti-VEGF (bevacizumab)). In this patient population, special attention was paid to intensified treatment regimens in order to improve their efficiency and improving the tumoral response rate, the intensity of the response and its earliness correlate with improved overall and progression-free survival. The intra-arterial use of oxaliplatin coupled with IV chemotherapy has yielded OR levels of 64% in patients having survived one or more lines of chemotherapy IV and 62% in patients who have progressed on oxaliplatin IV. In addition, the HIA administration of oxaliplatin limits systemic and especially neurological toxicities, thanks to a greater hepatic clearance. In conclusion, the combination of systemic chemotherapy, targeted therapy and HIAC with oxaliplatin has showed promising efficacy results associated with good tolerance from the first line onwards. Indeed, we can expect from the Phase II recent data, a control rate close to 100%, with high response rates associated with early maturity and depth responses as well as prolonged survival. However, to date, in the absence of randomized trial testing this combination, this strategy does not have sufficient evidence to be integrated in our routine practices, and HIAC remains limited to a few expert centers in treatment catch-up.
Trial Details
NCT Number NCT02885753
Lead Sponsor Federation Francophone de Cancerologie Digestive
Conditions
(from sponsor)
Colorectal Neoplasms
Related terms Colorectal Neoplasms, Neoplasm Metastasis, Neoplasms
Enrollment 348 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov