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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Drug: oxaliplatin


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FOLFOX_12 or CAPOX_8<br>6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX | Drug: oxaliplatin<br>* 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.<br>* Other names: oxaliplatin (modified FOLFOX-6 OR CAPOX);|
| Experimental: FOLFOX_6 or CAPOX_4<br>3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX | Drug: oxaliplatin<br>* 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.<br>* Other names: oxaliplatin (modified FOLFOX-6 OR CAPOX);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 years | 
| quality of life |  | 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. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adjuvant FOLFOX or CAPOX Therapy, Stage II/III Colon Cancer, Adjuvant Therapy