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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer

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Trial Information

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. 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease-free survival

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Young Suk Park, M.D.,Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center, Seoul, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

2009-11-008

NCT ID:

NCT01092481

Start Date:

January 2010

Completion Date:

December 2016

Related Keywords:

  • Colon Cancer
  • Adjuvant FOLFOX or CAPOX Therapy
  • Stage II/III Colon Cancer
  • Adjuvant Therapy
  • Colonic Neoplasms

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