At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 530 enrolled

Drug / intervention

Docetaxel (XRP6976) +2 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01515748

NCT01515748Phase 3Completed

Compare CT.gov

A Phase III, Open-labelled, Randomised Study of Neoadjuvant Docetaxel+Oxaliplatin+S-1 (DOS) + Surgery + Adjuvant S-1 Versus Surgery + Adjuvant S-1 in Patients With Resectable Advanced Gastric Cancer

Sanofi·interventional·Posted Jan 24, 2012·Updated Dec 13, 2023

In Brief

A Phase 3 clinical trial evaluating Docetaxel (XRP6976), Oxaliplatin (SR96669), and 1 other intervention for Gastric Cancer. Completed, enrolled 530 participants across 1 site.

Detailed Summary

Primary Objective: \- To compare the 3-year progression free survival (PFS) in the two treatment arms. Secondary Objectives: * Overall survival (OS). * Postoperative pathological stage and R0 (complete) resection rate. * Safety: Toxicities associated with neoadjuvant chemotherapy, surgery, morbidity/mortality, toxicity of adjuvant chemotherapy.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsGastric Cancer

CountriesSouth Korea

Collaborators--

Timeline

Phase 3CompletedFinished

201220132014201520162017201820192020202120222023202420252026

Enrollment StartDec 2011

First PostedJan 2012

Primary CompletionJan 2019

Study CompletionDec 2021

TodayJul 2026

First PostedJan 24, 2012

Enrollment StartDec 30, 2011

Primary CompletionJan 21, 2019

Study CompletionDec 13, 2021

TodayJul 2, 2026

Enrollment to primary: 7.1 yearsPosted 14.4 years ago

Interventions

Docetaxel (XRP6976)drug

Pharmaceutical form:solution for infusion Route of administration: intravenous

Oxaliplatin (SR96669)drug

Pharmaceutical form:solution for infusion Route of administration: intravenous

S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil)drug

Pharmaceutical form:Tablet Route of administration: Oral