Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma
|ClinicalTrials.gov Identifier: NCT00816543|
Recruitment Status : Completed
First Posted : January 1, 2009
Last Update Posted : December 18, 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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: DOCETAXEL Drug: S-1 Drug: OXALIPLATIN||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm Phase II Feasibility Study of Neoadjuvant Docetaxel, Oxaliplatin and S-1 Chemotherapy in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma.|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
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.
- R0 resection rate [ Time Frame: At the end of the treatment period ]
- Physical examination [ Time Frame: Every 3 months during the study period ]
- Chest X-Ray [ Time Frame: Throughout the study period ]
- Computed Tomography scan of the abdomen [ Time Frame: Every 6 months during the study period ]
- Gastrofiberscopy [ Time Frame: Every 1 year from the completion of the treatment for 2 years ]
- Laboratory analysis [ Time Frame: Throughout the study period ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816543
|Korea, Republic of|
|Sanofi-Aventis Administrative Office|
|Seoul, Korea, Republic of|
|Study Director:||Faith Fung||Sanofi|