FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01566942
• Other study ID #: 2011-170
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 26, 2012
• Last updated: March 27, 2012
• Start date: June 2012
• Est. completion date: June 2017

Study information

• Verified date: March 2012
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 2017
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• histologically confirmed adenocarcinoma in colorectal cancer

• clinical stage ? or ?a(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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
China	the first affiliated hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes