Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma
This study has been completed.
Information provided by (Responsible Party):
First received: December 31, 2008
Last updated: December 17, 2012
Last verified: December 2012
The primary objective of this trial is:
- To determine whether it is feasible in locally advanced gastric or gastroesophageal cancer to administer 3 cycles of Docetaxel, Oxaliplatin and S-1 as a chemotherapy scheme and also to determine what toxicities are involved.
The secondary objective of this trial are to describe:
- The disease free survival at one and two years in that subgroup of patients that has undergone a R0 resection.
- The downstaging after 3 cycles of chemotherapy, pCR in that subgroup of patients that have undergone an R0 resection and progression-free survival and overall survival at one and two years.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Arm Phase II Feasibility Study of Neoadjuvant Docetaxel, Oxaliplatin and S-1 Chemotherapy in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- R0 resection rate [ Time Frame: At the end of the treatment period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Physical examination [ Time Frame: Every 3 months during the study period ] [ Designated as safety issue: No ]
- Chest X-Ray [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
- Computed Tomography scan of the abdomen [ Time Frame: Every 6 months during the study period ] [ Designated as safety issue: No ]
- Gastrofiberscopy [ Time Frame: Every 1 year from the completion of the treatment for 2 years ] [ Designated as safety issue: No ]
- Laboratory analysis [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy.
50 mg/m² IV as a 1 hour infusion on day 1 for each period of 3 weeks for 3 cycles.Drug: S-1
80mg/m² day 1-14 every 3 weeks for 3 cycles. The curative resection group will receive two oral doses of 40 mg/m²/day for 4 weeks, followed by 2 weeks rest, for 1 year.Drug: OXALIPLATIN
100 mg/m² on day 1 as a two-hour IV infusion for each period of 3 weeks for 3 cycles.
Contacts and Locations