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A Study Evaluating Regorafenib Following Completion of Standard Chemotherapy for Patients With Colon Cancer

NCT02664077 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-04-14

No results posted yet for this study

Summary

This study is a randomized, double-blind, post-chemotherapy, adjuvant phase III clinical trial. The primary aim of this study is to determine the value of regorafenib in improving disease-free survival (DFS). Patients with Stage III (IIIB or IIIC) colon cancer as defined by the 7th Edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual are randomized 1:1 to placebo or the experimental agent regorafenib following completion of at least four months of standard adjuvant therapy (e.g., 5-fluorouracil, leucovorin, oxaliplatin (FOLFOX) , capecitabine, oxaliplatin (CapeOx), and other).

Conditions

  • Stage III (IIIB or IIIC) Colon Cancer

Interventions

DRUG

Regorafenib

3 tablets once a day by mouth for 21 consecutive days of 28 day cycle for 26 cycles

DRUG

Placebo

3 tablets once a day by mouth for 21 consecutive days of 28 day cycle for 26 cycles

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • NSABP Foundation Inc

    lead NETWORK

Principal Investigators

  • Norman Wolmark, MD · NSABP Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT02664077 on ClinicalTrials.gov