Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01092481
Recruitment Status : Active, not recruiting
First Posted : March 25, 2010
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Young Suk Park, Samsung Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: oxaliplatin Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 26, 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: oxaliplatin (modified FOLFOX-6 OR CAPOX)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 3 years ]
  2. quality of life [ Time Frame: 3 years ]
  3. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092481


Locations
Layout table for location information
Korea, Republic of
Hallym University Medical Center
Anyang, Gyeonggi, Korea, Republic of, 431-070
Soon Chun Hyang University Hospital Bucheon
Bucheon, Gyeonggi, Korea, Republic of, 420-767
National Cancer Center
Goyang, Gyeonggi, Korea, Republic of, 410-768
School of Medicine, CHA University
Seongnam, Gyeonggi, Korea, Republic of, 463-712
Sungkyunkwan University Masan Samsung Hospital
Masan, Gyeongsangnam, Korea, Republic of, 630-522
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam, Korea, Republic of, 626-770
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam, Korea, Republic of, 519-809
Kosin Medical Center
Busan, Korea, Republic of, 602-702
Dong-A University Medical Center
Busan, Korea, Republic of, 602-715
Gachon University Gil Hospital
Incheon, Korea, Republic of, 405-760
Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Seoul St. Mary's hospital, Catholic Univerisity
Seoul, Korea, Republic of, 137-701
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Soonchunhyang University Hospital
Seoul, Korea, Republic of, 140-210
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of, 156-707
Chung-Ang University College of Medicine
Seoul, Korea, Republic of, 156-755
Sponsors and Collaborators
Samsung Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Young Suk Park, M.D.,Ph.D. Samsung Medical Center, Seoul, Korea
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Young Suk Park, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01092481     History of Changes
Other Study ID Numbers: 2009-11-008
2009-11-008 ( Other Identifier: Samsung Medical Center )
First Posted: March 25, 2010    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Keywords provided by Young Suk Park, Samsung Medical Center:
Adjuvant FOLFOX or CAPOX Therapy
Stage II/III Colon Cancer
Adjuvant Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Leucovorin
Oxaliplatin
Fluorouracil
 Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances