Cisplatin,Docetaxel and S-1 for Advanced Gastric and Gastroesophageal Junction Cancer
|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: taxotereDrug: Cisplatin Drug: S-1
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747707
|Contact: Aiping Zhou, M.Dfirstname.lastname@example.org|
|Contact: Yongkun Sun, M.Demail@example.com|
|Cancer Hospital & Institute, Chinese Academy of Medical Sciences||Recruiting|
|Beijing, China, 10021|
|Contact: Yongkun Sun, M.D 8610-87788145 firstname.lastname@example.org|
|Principal Investigator:||Aiping Zhou, M.D||Cancer Hospital & Institute, Chinese Academy of Medical Sciences|