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

NCT00816543 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2012-12-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

DOCETAXEL

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.

Sponsors & Collaborators

Principal Investigators

  • Faith Fung · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00816543 on ClinicalTrials.gov