FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer

Phase 3UnknownNCT01566942

Sun Yat-sen University200 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Colorectal Cancer

Interventions

OxaliplatinDRUG

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

IrinotecanDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

the first affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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.

Time frame: 3-year disease-free survival rate

Secondary Outcomes

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.

Time frame: 5-year survival

Data from ClinicalTrials.gov

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