Early Commencement of Adjuvant Chemotherapy for Colon Cancer

Study Overview
=================
Brief Summary
-----------------
This study sets up the final study end point and three detailed goals as the following. The main objective of study: This trial is done to assess the safety and benefit of early adjuvant chemotherapy from 10 to 14 days after surgery compared with conventional commencement after 2weeks for treatment of patients with colon cancer. Detailed goal of study: The primary endpoint: This study is designed to assess whether early commencement of adjuvant chemotherapy improves the 3-year disease-free survival, overall survival and recurrence rate. The secondary endpoint: This study aims to compare short-term cumulative complications between early and conventional commencement of adjuvant chemotherapy after laparoscopic resection of colon cancer. This study will also assess the quality of life and side effects of chemotherapy.

Detailed Description
-----------------
Chemotherapy regimen: FOLFOX-6, every 2weeks, total 12 cycles treatment day1: Oxaliplatin 85mg/m2 day1: Leucovorin 200mg/m2 day1: 5-FU 400mg/m2 IV bolus 2,400mg/m2 over 46 hours

Official Title
-----------------
Early Commencement of Adjuvant Chemotherapy for Stage III Colon Cancer: a Multicenter Randomized Trial

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

Intervention / Treatment
-----------------
* Procedure: timing to initiate the adjuvant chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligibility rule of enrollment Rectal adenocarcinoma that were 15 cm or more from the anal verge pathologically diagnosed stage II or III disease patients who meet the discharge criteria within 10days after surgery Patients with adequate hepatic, renal, and bone marrow function, and a left ventricular ejection fraction of 55% or higher measured by echocardiography Exclusion Criteria: An ineligibility to participate in the clinical study based on the judgment of investigators from a legal perspective A past history of chemotherapy tumor with obstruction or perforation tumor with distant metastases synchronous tumor relative or absolute contraindications of chemotherapy Recent MI, CVA, nitrate medication Severe cardiovascular disease, psychiatric disease Severe hepatic dysfunction (GOT, GPT ≥100IU/L) Renal dysfunction (Cr ≥2mg/dl) The concurrent presence of other severe medical diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: early commencement<br>Individuals who initiate the adjuvant chemotherapy from 10 to 14 days after surgery | Procedure: timing to initiate the adjuvant chemotherapy<br>* Chemotherapy regimen: FOLFOX-6, every 2weeks, total 12 cycles treatment day1: Oxaliplatin 85mg/m2 day1: Leucovorin 200mg/m2 day1: 5-FU 400mg/m2 IV bolus and 2,400mg/m2 over 46 hours<br>* Other names: early commencement of chemotherapy;|
| Active Comparator: conventional commencement<br>Individuals who initiate the adjuvant chemotherapy after 14 days after surgery | Procedure: timing to initiate the adjuvant chemotherapy<br>* Chemotherapy regimen: FOLFOX-6, every 2weeks, total 12 cycles treatment day1: Oxaliplatin 85mg/m2 day1: Leucovorin 200mg/m2 day1: 5-FU 400mg/m2 IV bolus and 2,400mg/m2 over 46 hours<br>* Other names: early commencement of chemotherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival rate | A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test. | up to 3 years after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| short-term cumulative surgery-related complications during chemotherapy | A comparison of the postoperative recovery variables, the postoperative complications and mortality | up to 26 weeks after operation | 
| side effects of chemotherapy | check Anemia, Leukopenia, Neutropenia, Thrombocytopenia, Edema, Fever, Insomnia, Asthenia, Anorexia, Nausea, Vomiting, Constipation, Diarrhea, Hand foot syndrome, Dyspepsia, Creatinine, AST, ALT, Bilirubin, abdominal pain, GI bleeding, diarrhea | during chemotherapy period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colon cancer, Chemotherapy, adjuvant