FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT01566942|
Recruitment Status : Unknown
Verified March 2012 by Yulong He, Sun Yat-sen University.
Recruitment status was: Not yet recruiting
First Posted : March 30, 2012
Last Update Posted : March 30, 2012
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Oxaliplatin Drug: Irinotecan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||June 2012|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||June 2017|
Active Comparator: FOLFOX
In this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6.
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
in this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles
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
- disease-free survival（DFS） [ Time Frame: 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.
- overall survival(OS) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566942
|the first affiliated hospital of Sun Yat-sen University||Not yet recruiting|
|Guangzhou, Guangdong, China, 510080|
|Contact: JIANJUN PENG, PhD 86-20-87332200 ext 8211 email@example.com|
|Study Chair:||YULONG HE, PhD||First Affiliated Hospital, Sun Yat-Sen University|