FOLFOXIRI Compared to FOLFOX in First Line Treatment of Metastatic Colorectal Cancer
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128425
|Contact: Yanhong Deng, M.D.||email@example.com|
|Gastrointestinal Hospital, Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510655|
|Contact: Yanhong Deng, M.D. 008613925106525 firstname.lastname@example.org|
|Principal Investigator: Yanhong Deng, M.D.|
|Principal Investigator:||Yanhong Deng, M.D.||Sixth Affiliated Hospital, Sun Yat-sen University|