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

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ClinicalTrials.gov Identifier: NCT01092481
Recruitment Status : Unknown
Verified May 2019 by Young Suk Park, Samsung Medical Center.
Recruitment status was:  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
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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
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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
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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
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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
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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
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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
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Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Young Suk Park, M.D.,Ph.D. Samsung Medical Center, Seoul, Korea
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Young Suk Park, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01092481    
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:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Oxaliplatin
Antineoplastic Agents