Cisplatin,Docetaxel and S-1 for Advanced Gastric and Gastroesophageal Junction Cancer
The combination of Cisplatin and S-1 (CS) achieved a response rate of approximately 45% with the PFS being around 6 months and overall survival time being 13 months in Japanese and Chinese gastric patients. It remains unclear whether the addition of docetaxel to CS would further enhance the efficacy as it dose in DCF(docetaxel, cisplatin and 5-fluorouracil). This is a single center, phase II clinical trial to evaluate the efficacy of docetaxel, cisplatin and S-1 (DCS) as first line chemotherapy for patients with advanced gastric and gastroesophageal junction cancer.
Gastroesophageal Junction Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Clinical Trial of Cisplatin,Docetaxel and S-1 as First Line Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer|
- overall survival time (OS) [ Time Frame: 14 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]To determine the PFS of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer
- safety profile [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]To determine the tolerability of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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
This is a single arm trial. All Patients will receive up to 6 cycles of triple chemotherapy with docetaxel, cisplatin and S-1. Given the severe toxicity of DCF regimen, here the total dose of docetaxel and cisplatin is both reduced to 60mg/m2. For patients with CR/PR/SD disease after 6 cycles of chemotherapy, maintenance therapy with S-1 are recommended. Antitumor activity will be evaluated every two cycles according to RECIST1.1.
Please refer to this study by its ClinicalTrials.gov identifier: 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|