Low-dose Capecitabine Adjuvant Chemotherapy for Elderly Patients With Stage II/III Colorectal Cancer (LcACEC)
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|ClinicalTrials.gov Identifier: NCT02316535|
Recruitment Status : Unknown
Verified September 2016 by Ziqiang Wang,MD, West China Hospital.
Recruitment status was: Recruiting
First Posted : December 15, 2014
Last Update Posted : September 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Drug: Capecitabine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||710 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Low-dose Versus Standard-dose Capecitabine Adjuvant Chemotherapy for Chinese Elderly Patients With Stage II/III Colorectal Cancer: A Randomized, Phase 3 Non-inferiority Study|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||May 2018|
Active Comparator: standard-dose
capecitabine, oral administration, 1,250 mg/m2 twice daily on days 1-14, and repeated on day 22; 8 circles in total.
Other Name: Xeloda
capecitabine, oral administration, 1,000 mg/m2 twice daily on days 1-14, and repeated on day 22; 8 circles in total.
Other Name: Xeloda
- disease free survival [ Time Frame: 3 years ]
- overall survival [ Time Frame: 3 years ]
- toxic and adverse effects [ Time Frame: 30 weeks ]
- completion rate [ Time Frame: 24 weeks ]
- quality of life [ Time Frame: 3 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): NCT02316535
|Contact: Yazhou He, MDfirstname.lastname@example.org|
|Contact: Xiangbing Deng, MDemail@example.com|
|Principal Investigator:||Ziqiang Wang, MD/PhD||West China Hospital|