FOLFOXIRI Compared to FOLFOX in First Line Treatment of Metastatic Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT02128425|
Recruitment Status : Unknown
Verified April 2014 by Yanhong Deng, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : May 1, 2014
Last Update Posted : May 7, 2014
The purpose of the study is to evaluate if the exposure to all the three active cytotoxic agents (FOLFOXIRI regimen) is superior in terms of progression-free survival to conventional chemotherapy with the FOLFOX regimen as first-line treatment of chemo-naive metastatic colorectal cancer patients.
A second primary aim is to evaluate the response rate, safety and tolerability of the chemotherapy of FOLFOXIRI regimen in this patient population.
Patients will be randomized to two therapy groups:
Experimental arm A: Chemotherapy with FOLFOXIRI Standard arm B: Chemotherapy with FOLFOX
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: FOLFOXIRI Drug: FOLFOX||Phase 2|
Survival of patients with metastatic colorectal cancer is correlated with the proportion of patients who receive all the three active drugs , but not with the proportion of patients who receive any second-line therapy. A superior efficacy in PFS,ORR and OS of FOLFOXIRI has been reported with acceptable toxicity. Moreover,evidence suggests that continuous dosing metronomic chemotherapy may be more efficacious than interval-chemotherapy.
Therefore, a way to improve the outcome of metastatic colorectal cancer patients could be to administer a maintenance first-line regimen containing the three active agents.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Randomized Controlled Trial of FOLFOXIRI Compared to FOLFOX in First Line Treatment of Chemo-naive Metastatic Colorectal Cancer|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||April 2018|
irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 3200 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle
*reduced in UGT1A1 7/7 patients
Active Comparator: FOLFOX
oxaliplatin 85 mg/m² + leucovorin 400 mg/m² +5-FU 400mg/m² bolus iv.+ 5-FU 2400 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle
- Progression-free survival after induction and maintenance chemotherapy (PFS1) [ Time Frame: up to 18 months ]Progressions are evaluated every 8 weeks according to WHO criteria and reviewed by an independent panel at the end of follow up (36 months).
- Progression-free survival after re-introduction of chemotherapy (PFS2) [ Time Frame: up to 24 months ]
- Response rate during re-introduction of chemotherapy [ Time Frame: up to 12 months ](CR + PR rate according to RECIST)
- Early tumor shrinkage rate in 8 weeks after induction treatment [ Time Frame: 8 weeks ]
- Overall survival [ Time Frame: up to 5 years ]
- toxicity and safety [ Time Frame: up to 24 months ]Number of participants with adverse events as a measure of safety and tolerability according to NCI CTC 4.0
- QLQ (QLQ C30) - scores according to EORTC QLQ-C30 scoring manual (Quality of life) [ Time Frame: up to 36 months ]
- Translational research [ Time Frame: up to 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128425
|Contact: Yanhong Deng, M.D.||firstname.lastname@example.org|
|Gastrointestinal Hospital, Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510655|
|Contact: Yanhong Deng, M.D. 008613925106525 email@example.com|
|Principal Investigator: Yanhong Deng, M.D.|
|Principal Investigator:||Yanhong Deng, M.D.||Sixth Affiliated Hospital, Sun Yat-sen University|