Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) in Patients With Advanced Gastric Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01980407|
Recruitment Status : Unknown
Verified November 2013 by Zhang Yue, Jilin Provincial Tumor Hospital.
Recruitment status was: Recruiting
First Posted : November 11, 2013
Last Update Posted : March 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: S-1, leucovorin, oxaliplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety and Efficacy Study of S-1, Oxaliplatin, and Leucovorin (SOL) in Patients With Advanced Gastric Cancer|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||March 2016|
Experimental: SOL, single arm
S-1 combined with leucovorin and oxaliplatin
Drug: S-1, leucovorin, oxaliplatin
S-1 (20mg), capsule, 40-60mg, bid, p.o., day1-14； Leucovorin (15 mg), tablet, 30mg,Bid, p.o., day1-14; Oxaliplatin (50 mg), injection 85mg/m2, day1.
- Response rate [ Time Frame: 6-8 weeks ]Evaluate the objective response rate followed by RECIST 1.1.
- Adverse events [ Time Frame: 1 year ]Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, The number of Participants with adverse events will be recorded at each treatment visit.
- Overall survival [ Time Frame: 3 year ]
- Progress free survival [ Time Frame: up to 9 weeks ]Tumor assessment will be performed every 3 cycles (9 weeks) from the start of treatment until progression or as for the metastatic site developed during the study (including clinical suspicion). In order to confirm objective tumor response, additional confirmatory scan should be obtained at least 4 weeks following the first radiological evidence of tumor response.
- Disease control rate [ Time Frame: up to 9 weeks ]To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
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): NCT01980407
|Contact: Yue Zhang, MD, Ph.D||+86-0431-85872596||JPCH2013@163.com|
|Jilin Provincial Tumor Hospital||Recruiting|
|Changchun, Jilin, China|