FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer

Phase 3

• Conditions: Colorectal Cancer
• Interventions: Drug: Oxaliplatin; Drug: Irinotecan

• Registration Number: NCT01566942
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-03
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-27
• Last Update Submitted: 2012-03-27
• Study First Posted: 2012-03-30
• Last Update Posted: 2012-03-30
• Study Start: 2012-06
• Primary Completion: 2014-05
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOLFOX	Oxaliplatin	In this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6.
FOLFIRI	Irinotecan	in this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

the first affiliated hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China