Combination Chemotherapy After Surgery in Treating Patients With High-Risk Stage II or Stage III Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00749450|
Recruitment Status : Unknown
Verified April 2012 by Laura Alexander, Cancer Research UK, Glasgow.
Recruitment status was: Recruiting
First Posted : September 9, 2008
Last Update Posted : April 24, 2012
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which combination chemotherapy regimen is more effective in treating patients who have undergone surgery for high-risk colorectal cancer.
PURPOSE: This randomized phase III trial is studying chemotherapy given after surgery in treating patients with high-risk stage II or stage III colorectal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: capecitabine Drug: fluorouracil Drug: oxaliplatin||Phase 3|
- To assess the efficacy and compare the associated toxicity of adjuvant chemotherapy lasting 12 weeks vs 24 weeks in patients with fully resected high-risk stage II or III colorectal cancer.
- To conduct an economic analysis of the cost effectiveness of these regimens.
- To compare the randomization methodologies used in this study.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center's recruitment potential. Patients are randomized (within 10 weeks after surgery and before or after receiving 12 weeks of chemotherapy) to 1 of 2 treatment arms. The treatment regimen that a patient receives (Oxaliplatin Modified DeGramont [OxMdG] or XELOX) is determined by the participating center.
- Arm I: Patients receive 12 courses of OxMdG (described below) or XELOX (described below)combination chemotherapy (6 additional courses if patient already received 6 courses) for treatment lasting a total of 24 weeks.
- Arm II: Patients receive 6 courses of OxMdG or XELOX combination chemotherapy (no additional courses if patient already received 6 courses) for treatment lasting a total of 12 weeks.
The two adjuvant combination chemotherapy regimens are administered as follows:
- OxMdG: Patients receive oxaliplatin IV over 2 hours and fluorouracil IV continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- XELOX: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality-of-life assessments periodically using the EORTC QLQ-C30, EORTC QLQ-CR29, EQ-5D, and GOG Ntx4 questionnaires.
After completion of study treatment, patients are followed periodically for up to 7 years.
Peer Reviewed and Funded by Medical Research Council (MRC)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Short Course Oncology Therapy - A Study of Adjuvant Chemotherapy in Colorectal Cancer|
|Study Start Date :||March 2008|
|Estimated Primary Completion Date :||March 2013|
Experimental: Arm I
Patients receive OxMdG or XELOX combination chemotherapy for a total of 12 courses for treatment lasting a total of 24 weeks.
Experimental: Arm II
Patients receive OxMdG or XELOX combination chemotherapy for a total of 6 courses for treatment lasting a total of 12 weeks.
- 3-year disease-free survival [ Time Frame: 3 years ]
- Overall survival [ Time Frame: assessed during 5 year recruitment period and maximum 7 year follow up period ]
- Cost-effectiveness [ Time Frame: assessed during 5 year recruitment period ]
- Toxicity according to NCI CTCAE Version 3.0 [ Time Frame: assessed during 5 year recruitment period ]
- Quality of life as assessed by EORTC QLQ-C30, EORTC QLQ-CR29, EQ-5D, and GOG Ntx4 [ Time Frame: assessed during 5 year recruitment period ]
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): NCT00749450
|Beatson West of Scotland Cancer Centre||Recruiting|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Contact: Tim Iveson, FRCP, MD, MRCP, MBBS, BSC 02380796802 firstname.lastname@example.org|
|Principal Investigator:||Tim Iveson, FRCP, MD, MRCP, MBBS, BSC||University Hospital Southampton NHS Foundation Trust|