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

NCT03043729 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2023-02-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Oxaliplatin

Oxaliplatin 85 mg/m\^2, as 2h infusion on Day 1 (Arm A + Arm B)

DRUG

5-FU

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)

DRUG

Leucovorin

Leucovorin 350 mg/m\^2 i.v. as 2h infusion on Day 1 (Arm A + Arm B)

BIOLOGICAL

Aflibercept

Aflibercept 4 mg/kg BW i.v. on Day 1 q2w (Arm B, Cycles 1 to 5)

Sponsors & Collaborators

  • Institut für Klinisch-Onkologische Forschung (IKF) Frankfurt

    collaborator UNKNOWN

  • Sanofi

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Ralf-Dieter Hofheinz, Prof. Dr. · Tagestherapiezentrum am ITM & III. Med. Klinik, Universitätsmedizin Mannheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-06
Primary Completion
2021-01-11
Completion
2022-06-01

Countries

  • Germany

Study Locations

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Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03043729 on ClinicalTrials.gov