Perioperative Treatment of Resectable Liver Metastases

Sponsor
University of Regensburg
Study ID
NCT01540435
Phase
PHASE2
Status
Withdrawn

Conditions

  • Colon Cancer Liver Metastasis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) + FOLFOXIRI in a biweekly schedule, 6 cycles preoperatively, 6 cycles postoperatively

Study Details

This randomized, controlled, multicenter, non-comparative phase II trial compares an intensified perioperative treatment of patients with resectable synchronous or metachronous colorectal liver metastases to primary surgery and adjuvant systemic chemotherapy.

Key Dates

First listed
Feb 28, 2012
Start date
Sep 30, 2012
Status verified
May 2013
Primary completion
May 31, 2013
Completion
May 31, 2013

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Postoperative Arm (Arm A)
    FOLFOX: Oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/m2 iv over 48 hours (day 1-3) Duration of treatment: Treatment will be administered for 12 cycles (6 months) postoperatively starting 6 weeks after surgery.
  • Experimental: Perioperative Arm (Arm B)
    Therapy will be administered in a biweekly schedule. First preoperative cycle will be administered with 75% of dosage for FOLFOXIRI, if no diarrhea ≥ grade 3 occurs, following cycles should be administered in full dosage. FOLFOXIRI + bevacizumab: bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) irinotecan at a dose of 165 mg/m2 iv over two hours (day 1) oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/m2 iv over 48 hours (day 1-3) Duration of treatment: Treatment will be administered for 6 cycles (3 months) preoperatively (last cycle without bevacizumab), after 6 weeks followed by liver surgery, after further 6 weeks followed by 6 cycles (3 months) postoperatively.

Primary Outcome Measure

Failure-free survival (FFS@18) [ Time Frame: 18 months ]

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