Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma
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|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.
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.
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 ]
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): NCT00816543
|Korea, Republic of|
|Sanofi-Aventis Administrative Office|
|Seoul, Korea, Republic of|
|Study Director:||Faith Fung||Sanofi|