A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC

Sponsor
Sun Yat-sen University
Study ID
NCT03303495
Phase
PHASE3
Status
Recruiting
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Conditions

  • Colorectal Neoplasms
  • Digestive System Neoplasms
  • Gastrointestinal Neoplasms
  • Intestinal Neoplasms
  • Neoplasm Metastasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.
  • CPT-11 — DRUG
    180 mg/m2 intravenously administered over 90 minutes on day 1 of a 2-week cycle
  • 5-FU Bolus — DRUG
    400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.
  • 5-FU Infusion — DRUG
    2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.
  • l-LV (dl-LV) — DRUG
    200 (dl-LV: 400) mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.

Study Details

The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.

Key Dates

First listed
Oct 6, 2017
Start date
Nov 14, 2011
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FOLFIRI +/- Bevacizumab
    Bevacizumab 5 mg/kg IV 90-30 min Day 1; CPT-11 180 mg/m2 IV 90 min Day 1; l-LV (dl-LV) 200 mg/m2 (400 mg/m2) IV 120 min Day 1; 5-FU - bolus 400 mg/m2 IV bolus Day 1; 5-FU - infusional 2400 mg/m2 IV continuous (46 hours) Day 1 - 3
  • Experimental: CPT-11 +/- Bevacizumab
    Bevacizumab 5 mg/kg IV 90-30 min Day 1; CPT-11 180 mg/m2 IV 90 min Day 1

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Assessed until 1.5 years after the last patient enrolment ]

Central Contacts

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