Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer

Sponsor
Grupo Espanol Multidisciplinario del Cancer Digestivo
Study ID
NCT02340949
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept — DRUG
    Administered I.V. at doses of 4 mg/Kg on Day 1 every 14 days. It will be supplied to sites by Sponsor as 4 ml vials at a concentration of 25 mg/ml
  • 5-Fluoruracil — DRUG
    Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2
  • Oxaliplatin — DRUG
    Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU
  • Leucovorin — DRUG
    Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU

Study Details

This trial compares induction treatment with FOLFOX with or without aflibercept in a high risk population selected by MRI, prior to receiving standard chemoradiation (capecitabine combined with 50.4 Gy in 28 days) and surgery, in order to evaluate the efficacy in terms of pathologic complete response (pCR).

Key Dates

Start date
Jan 31, 2015
Status verified
Apr 2021
Primary completion
Jul 15, 2019
Completion
Feb 4, 2020

Study Design

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

Arms

  • Experimental: mFOLFOX6 + Aflibercept
    \- mFOLFOX-6 scheme: 5-Fluoruracil \[5-FU\], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme: Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m². \- Aflibercept, will be administered intravenously (I.V.) at doses of 4 mg/Kg on Day 1 every 14 days. Aflibercept will be supplied to sites by the study Sponsor as 4 ml vials at a concentration of 25 mg/ml. Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs.
  • Active Comparator: mFOLFOX6
    \- mFOLFOX-6 scheme: 5-Fluoruracil \[5-FU\], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme: Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m². Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs.

Primary Outcome Measure

Number of Patients Achieving Pathologic Complete Response (pCR). [ Time Frame: From baseline until 2 years and 2 months ]

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