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

Samsung Medical Center1,580 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,580

Conditions

Colon Cancer

Interventions

oxaliplatinDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Hallym University Medical Center

Anyang-si, Gyeonggi-do, South Korea

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

disease-free survival

Time frame: 3 years

Secondary Outcomes

overall survival

Time frame: 3 years

quality of life

Time frame: 3 years

safety profiles

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.

Time frame: 3 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.