Study Investigating the Role of Oxaliplatin Duration in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Colon Cancer Therapy

May 17, 2019 updated by: Young Suk Park, Samsung Medical Center

A Randomized Phase III Study Investigating the Role of Oxaliplatin Duration (3 Months Versus 6 Months) in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Therapy for Patients With Stage II/III Colon Cancer

This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer. In addition, we would like to characterize pharmacogenomic profile associated with toxicities and gene expression profiling to predict the recurrence of colon cancer as parallel study.

Study Type

Interventional

Enrollment (Actual)

1580

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Dong-A University Medical Center
      • Busan, Korea, Republic of, 602-702
        • Kosin Medical Center
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 156-707
        • SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University College of Medicine
      • Seoul, Korea, Republic of, 137-701
        • Seoul St. Mary's hospital, Catholic Univerisity
      • Seoul, Korea, Republic of, 140-210
        • Soonchunhyang University Hospital
      • Seoul, Korea, Republic of, 156-755
        • Chung-Ang University College of Medicine
    • Gyeonggi
      • Anyang, Gyeonggi, Korea, Republic of, 431-070
        • Hallym University Medical Center
      • Bucheon, Gyeonggi, Korea, Republic of, 420-767
        • Soon Chun Hyang University Hospital Bucheon
      • Goyang, Gyeonggi, Korea, Republic of, 410-768
        • National Cancer Center
      • Seongnam, Gyeonggi, Korea, Republic of, 463-712
        • School of Medicine, CHA University
    • Gyeongsangnam
      • Masan, Gyeongsangnam, Korea, Republic of, 630-522
        • Sungkyunkwan University Masan Samsung Hospital
      • Yangsan, Gyeongsangnam, Korea, Republic of, 626-770
        • Pusan National University Yangsan Hospital
    • Jeollanam
      • Hwasun, Jeollanam, Korea, Republic of, 519-809
        • Chonnam National University Hwasun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Curatively resected, histologically confirmed colon adenocarcinoma
  • AJCC/UICC high-risk stage II, stage III colon cancer
  • Age over 18 years old
  • Performance status (ECOG scale): 0-1
  • Adequate major organ functions
  • Patients should sign a written informed consent before study entry

Exclusion Criteria:

  • Colon cancer other than adenocarcinoma
  • Rectal cancer
  • R1 or R2 resections
  • Other malignancies within the last 5 years
  • Symptomatic peripheral sensory neuropathy
  • Presence of other serious disease
  • Lactating or pregnant women
  • Fertile women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FOLFOX_12 or CAPOX_8
6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
Drug: oxaliplatin
to confirm that first 3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.
Other Names:
  • oxaliplatin (modified FOLFOX-6 OR CAPOX)
Experimental: FOLFOX_6 or CAPOX_4
3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
Drug: oxaliplatin
to confirm that first 3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.
Other Names:
  • oxaliplatin (modified FOLFOX-6 OR CAPOX)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease-free survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 3 years
3 years
quality of life
Time Frame: 3 years
3 years
safety profiles
Time Frame: 3 years
Safety will be assessed on the basis of an analysis of adverse events, standard clinical chemistry and hematology findings. Clinical and laboratory toxicities/symptoms will be graded according to the CTCAE 3.0. Adverse events which are not reported in CTCAE 3.0 will be graded as mild, moderate, severe or life threatening.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Young Suk Park, M.D.,Ph.D., Samsung medical center, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2010

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 22, 2009

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Actual)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-11-008 (Other Identifier: Samsung Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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