Study to Evaluate the Efficacy of FOLFOX + Panitumumab Followed by FOLFIRI + Bevacizumab (Sequence 1) Versus FOLFOX + Bevacizumab Followed by FOLFIRI + Panitumumab (Sequence 2) in Untreated Patients With Wild-type RAS Metastatic, Primary Left-sided, Unresectable Colorectal Cancer

Sponsor
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Study ID
NCT03635021
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • FOLFOX regimen — DRUG
    oxaliplatin 85 mg/m2 administered by IV infusion over 120 minutes on Day 1, L-leucovorin 200 mg/m2 administered as a 2-hour IV infusion on Day 1 and 5-FU 400 mg/m2 administered as IV bolus over approximately 2 to 4 minutes on Day 1 followed by 5-FU 2400 mg/m2 administered as IV infusion over 46- 48 hours on Days 1 and 2
  • Panitumumab — DRUG
    6 mg/kg administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 14-day cycle
  • Bevacizumab — DRUG
    5 mg/kg administered by IV infusion over 60 minutes on Day 1 of each 14-day cycle
  • FOLFIRI regimen — DRUG
    irinotecan 180 mg/m2 administered as a 90 minutes IV infusion on Day 1, L-leucovorin 200 mg/m2 administered as a 2-hour IV infusion on Day 1 and 5-FU 400 mg/m2 administered as IV bolus over approximately 2 to 4 minutes on Day 1 followed by 5-FU 2400 mg/m2 administered as IV infusion over 46-48 hours on Days 1 and 2

Study Details

The purpose of this study is to assess the efficacy of FOLFOX + panitumumab followed by FOLFIRI + bevacizumab (Sequence 1) versus FOLFOX + bevacizumab followed by FOLFIRI + panitumumab (Sequence 2) in untreated patients with wild-type RAS metastatic, primary left-sided, unresectable colorectal cancer

Key Dates

First listed
Aug 17, 2018
Start date
Oct 15, 2018
Status verified
Oct 2024
Primary completion
Jun 28, 2025
Completion
Jun 28, 2025

Study Design

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

Arms

  • Experimental: Sequence 1
    FOLFOX regimen panitumumab FOLFIRI regimen bevacizumab
  • Experimental: Sequence 2
    FOLFOX regimen bevacizumab FOLFIRI regimen panitumumab

Primary Outcome Measure

Progression-free survival rate at 35 months [ Time Frame: 35 months after date of randomization ]

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