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Study of Colorectal Cancer Patients (Stage IIIC) With Either Regorafenib or Standard of Care (No Treatment) After Adjuvant FOLFOX

NCT02425683 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-02-10

No results posted yet for this study

Summary

This study, for patients who have Stage IIIC colorectal cancer and who underwent 5-fluorouracil/leucovorin with oxaliplatin (FOLFOX) chemotherapy after surgery, will test to see if regorafenib given after the completion of FOLFOX improves treatment, compared to standard of care (SOC), which is no further treatment.

Conditions

  • Colorectal Neoplasms
  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum

Interventions

DRUG

Regorafenib

120 mg or 160 mg by mouth each day for first 21 days of each 28-day cycle, for maximum of 6 cycles

Sponsors & Collaborators

  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

    collaborator INDUSTRY

  • US Oncology Research

    lead INDUSTRY

Principal Investigators

  • Thomas H. Cartwright, MD · US Oncology Research, McKesson Specialty Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-26
Primary Completion
2017-09-21
Completion
2017-09-21

Countries

  • United States

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Entities

Drugs

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 NCT02425683 on ClinicalTrials.gov