Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: DOCETAXEL; Drug: S-1; Drug: OXALIPLATIN

• Registration Number: NCT00816543
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-31
• Study First Submitted QC: 2008-12-31
• Study First Posted: 2009-01-01
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-17
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	S-1	3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy.
1	OXALIPLATIN	3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy.
1	DOCETAXEL	3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy.

Primary Outcome Measures

Name	Time	Method
R0 resection rate	At the end of the treatment period

Secondary Outcome Measures

Name	Time	Method
Computed Tomography scan of the abdomen	Every 6 months during the study period
Gastrofiberscopy	Every 1 year from the completion of the treatment for 2 years
Laboratory analysis	Throughout the study period
Physical examination	Every 3 months during the study period
Chest X-Ray	Throughout the study period

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇰🇷 Seoul, Korea, Republic of