FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer

Study Overview
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Brief Summary
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the aim of this study is to observe the effect of irinotecan-based regimen in patients with advanced colorectal cancer.

Official Title
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FOLFIRI or mFOLFOX6 as Adjuvant Chemotherapy Regiment After Neo-adjuvant Chemotherapy With FOLFIRI in Patients With Advanced Colorectal Cancer: a Randomized, Multicenter Clinical Trial

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Oxaliplatin
* Drug: Irinotecan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed adenocarcinoma in colorectal cancer clinical stage Ⅲ or Ⅳa(with potential radical resective metastatic lesions),≥ 12 lymph nodes examined no cancer cells were found in ascites Eastern Cooperative Oncology Group(ECOG) performance status of 0-2 male or female, between 18 and 75 years old adequate hematologic, hepatic and renal functions without severe heart disease in the last 6 months before enrolled. If with hypertension or coronary artery disease, it can be controlled not enrolled into others clinical trial during this study all patients should sign the informed consent Exclusion Criteria: can not be tolerated operation receiving others therapy(including Traditional Chinese herbs)for this disease, can not obey the investigator during the study can not be tolerated the adverse effect of drugs in these regimens major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from major surgery metastatic disease more than one organ pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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<br>In this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6. | Drug: Oxaliplatin<br>* In this arm, patients will receive the adjuvant chemotherapy with mFOLFOX6 regimen for 8 cycles. Oxaliplatin 85mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks<br>|
| Experimental: FOLFIRI<br>in this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles | Drug: Irinotecan<br>* In this arm, patients will receive the adjuvant chemotherapy with FOLFIRI regimen for 8 cycles. Irinotecan 180mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival（DFS） | The investigator will follow up all the enrolled patients. The difference of 3-year-DFS between two groups will be compared. | 3-year disease-free survival rate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival(OS) | The 5-year survival rate will be the secondary end point. The investigator will follow up the patients and campare the difference of 5-year-OS between the two groups. | 5-year survival | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FOLFIRI, FOLFOX, adjuvant chemotherapy, advanced colorectal cancer