mFOLFOX6 vs. mFOLFOX6 + Aflibercept as Neoadjuvant Treatment in MRI-defined T3-rectal Cancer

Sponsor
AIO-Studien-gGmbH
Study ID
NCT03043729
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Oxaliplatin — DRUG
    Oxaliplatin 85 mg/m\^2, as 2h infusion on Day 1 (Arm A + Arm B)
  • 5-FU — DRUG
    5-FU 400 mg/m\^2 i.v. as bolus on Day 1 and 2400 mg/m\^2 as 46 h infusion q2w (Arm A + Arm B)
  • Leucovorin — DRUG
    Leucovorin 350 mg/m\^2 i.v. as 2h infusion on Day 1 (Arm A + Arm B)
  • Aflibercept — BIOLOGICAL
    Aflibercept 4 mg/kg BW i.v. on Day 1 q2w (Arm B, Cycles 1 to 5)

Study Details

Patients with locally advanced rectal or rectosigmoid cancer staged cT3 CRM-negative with MRI will receive 6 cycles of neoadjuvant treatment with mFOLFOX6 (Arm A) vs. mFOLFOX6 + aflibercept (Arm B) followed by surgery.

Key Dates

Start date
Mar 6, 2017
Status verified
Feb 2023
Primary completion
Jan 11, 2021
Completion
Jun 1, 2022

Study Design

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

Arms

  • Active Comparator: Arm A
    6 cycles chemotherapy with Oxaliplatin 85 mg/m\^2 and Leucovorin 350 mg/m\^2 i.v. as 2h infusion on Day 1 and 5-FU 400 mg/m\^2 i.v. as bolus on Day 1 and 2400 mg/m\^2 as 46 h infusion q2w followed by surgery 4 weeks after last neoadjuvant chemotherapy treatment
  • Experimental: Arm B
    6 cycles chemotherapy with Oxaliplatin 85 mg/m\^2 and Leucovorin 350 mg/m\^2 i.v. as 2h infusion on Day 1 and 5-FU 400 mg/m\^2 i.v. as bolus on Day 1 and 2400 mg/m\^2 as 46 h infusionq2w + Aflibercept 4 mg/kg BW i.v. on Day 1 q2w (6th cycle without Aflibercept) followed by surgery 4 weeks after last neoadjuvant chemotherapy treatment

Primary Outcome Measure

Pathologic complete response (pCR) [ Time Frame: 20 weeks ]

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