FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01566942

Collaborator

First Affiliated Hospital, Sun Yat-Sen University (Other)

200

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: Oxaliplatin Drug: Irinotecan	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2012

Anticipated Primary Completion Date :

May 1, 2014

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: FOLFOX In this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6.	Drug: Oxaliplatin 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
Experimental: FOLFIRI in this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles	Drug: Irinotecan 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

Arm

Intervention/Treatment

Active Comparator: FOLFOX

In this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6.

Drug: Oxaliplatin

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

Experimental: FOLFIRI

in this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles

Drug: Irinotecan

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

Outcome Measures

Primary Outcome Measures

disease-free survival（DFS） [3-year disease-free survival rate]
The investigator will follow up all the enrolled patients. The difference of 3-year-DFS between two groups will be compared.

Secondary Outcome Measures

overall survival(OS) [5-year survival]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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