Cisplatin,Docetaxel and S-1 for Advanced Gastric and Gastroesophageal Junction 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: NCT01747707|
Recruitment Status : Unknown
Verified December 2012 by Aiping Zhou, Chinese Academy of Medical Sciences.
Recruitment status was: Recruiting
First Posted : December 12, 2012
Last Update Posted : December 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Gastroesophageal Junction Cancer||Drug: Docetaxel Drug: Cisplatin Drug: S-1||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Trial of Cisplatin,Docetaxel and S-1 as First Line Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||May 2014|
Experimental: docetaxel, cisplatin and S-1 (DCS)
All patients receive the combination therapy of docetaxel, cisplatin and S-1 for a maximum of 6 cycles. Docetaxel 60mg/m2 IV infusion over 1 hour on d1; Cisplatin 30mg/m2 IV infusion on d1,2; S-1 40mg orally twice a day for patients with the body surface area (BSA) less than 1.25m2, 50mg twice a day with the BSA between 1.25 and 1.5m2, 60mg twice a day with the BSA over 1.5m2.
Other Name: taxotere
Other Name: TS-1
- overall survival time (OS) [ Time Frame: 14 months ]To determine the OS of DCS in patients with chemo-naive, advanced gastric or gastroesophageal junction cancer.
- Progression free survival (PFS) [ Time Frame: 6 months ]To determine the PFS of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer
- safety profile [ Time Frame: 4 months ]To determine the tolerability of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer.
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): NCT01747707
|Contact: Aiping Zhou, M.Demail@example.com|
|Contact: Yongkun Sun, M.Dfirstname.lastname@example.org|
|Cancer Hospital & Institute, Chinese Academy of Medical Sciences||Recruiting|
|Beijing, China, 10021|
|Contact: Yongkun Sun, M.D 8610-87788145 email@example.com|
|Principal Investigator:||Aiping Zhou, M.D||Cancer Hospital & Institute, Chinese Academy of Medical Sciences|