Bevacizumab And Combination Chemotherapy in Rectal Cancer Until Surgery

Sponsor
University College, London
Study ID
NCT01650428
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    5 mg/kg, IV (in the vein) over 30-90 minutes, on day 1 of each 2 weekly cycles. Number of cycles: 1-5 (bevacizumab should not be administered during cycle 6).
  • Irinotecan — DRUG
    165 mg/m2 IV (intravenous) over 1 hour on day 1 of two weekly cycle. Number of cycles: 1-6
  • Oxaliplatin — DRUG
    165 mg/m2 IV (intravenous) over 1 hour on day 1 of two weekly cycle. Number of cycles: 1-6
  • 5-Fluorouracil — DRUG
    3200 mg/m2 IV (intravenous), continuous infusion over 48 hours starting on day 1 of two weekly cycle. Number of cycles: 1-6

Study Details

The purpose of this study is to evaluate the efficacy, toxicity and feasibility of FOLFOX/ bevacizumab and FOLFOXIRI/ bevacizumab neoadjuvant therapy in poor prognosis rectal cancer as defined by MRI.

Key Dates

Start date
Apr 30, 2013
Status verified
Oct 2018
Primary completion
Jan 10, 2018
Completion
Feb 14, 2019

Study Design

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

Arms

  • Experimental: FOLFOX & Bevacizumab
    Bevacizumab - 5 mg/kg IV over 30-90 minutes (cycles 1-5 only), Oxaliplatin - 85 mg/m2 IV over 2 hours, Folinic acid - 350 mg IV over 2 hours, 5-Fluorouracil - 3200 mg/m2 IV continuous infusion over 48 hour. Treatment given every 2 weeks for 12 weeks (for 6 cycles)
  • Experimental: FOLFOXIRI & Bevacizumab
    Bevacizumab - 5 mg/kg IV over 30-90 minutes (cycles 1-5 only), Irinotecan - 165 mg/m2 IV over 1 hour, Oxaliplatin - 85 mg/m2 IV over 2 hours, Folinic acid - 350 mg IV over 2 hours, 5-Fluorouracil - 3200 mg/m2 IV continuous infusion over 48 hour. Treatment given every 2 weeks for 12 weeks (for 6 cycles)

Primary Outcome Measure

Pathological Complete Response (PCR) [ Time Frame: The pCR rate will be assessed after surgery, therefore approximately 24 weeks after randomisation. ]

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