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Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer (PRODIGY)

This study is ongoing, but not recruiting participants.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01515748

First Posted: January 24, 2012

Last Update Posted: April 13, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Sanofi

Purpose

Primary Objective:

- To compare progression free survival (PFS) in the two treatment arms

Secondary Objectives:

Overall survival (OS)
Postoperative stage and R0 (complete) resection rate
Safety: Toxicities associated with neoadjuvant chemotherapy, surgery, morbidity/mortality, toxicity of adjuvant chemotherapy1

Condition	Intervention	Phase
Gastric Cancer	Drug: DOCETAXEL (XRP6976) Drug: OXALIPLATIN (SR96669) Drug: S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + CDHP (Gemeracil) + Oxo (Oteracil)	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Stomach Cancer

Drug Information available for: Oxaliplatin Docetaxel

Genetic and Rare Diseases Information Center resources: Stomach Cancer

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

Progression-Free Survival (PFS) [ Time Frame: Up to a maximum of 8 years ]
Overall survival (OS) [ Time Frame: Up to a maximum of 8 years ]
Post-operative pathological stage [ Time Frame: Up to a maximum of 24 weeks ]

Secondary Outcome Measures:

R0 resection rate [ Time Frame: Up to a maximum of 24 weeks ]


Estimated Enrollment:	640
Study Start Date:	January 2012
Estimated Study Completion Date:	January 2020
Estimated Primary Completion Date:	January 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: neoadjuvant chemotherapy + surgery + adjuvant chemotherapy Docetaxel 50 mg/m² for day 1 , Oxaliplatin 100 mg/m² for day 1, S-1 80 mg/m²/day from day 1 to day 14 + surgery + S-1 80 mg/m²/day for 1yr	Drug: DOCETAXEL (XRP6976) Pharmaceutical form:solution for infusion Route of administration: intravenous Drug: OXALIPLATIN (SR96669) Pharmaceutical form:solution for infusion Route of administration: intravenous
surgery + adjuvant chemotherapy surgery + S-1 80 mg/m²/day for 1yr	Drug: S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + CDHP (Gemeracil) + Oxo (Oteracil) Pharmaceutical form:Tablet Route of administration: Oral

Detailed Description:

Patients in the neoadjuvant chemotherapy arm will be treated for 3 cycles (1 cycle is 21 days) before surgery and treated for a year with TS-1 Patients in the adjuvant chemotherapy arm will get a surgery and treated for a year with TS-1. All patients will be followed during and after the study treatment until death or progression, whichever comes first.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	20 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria :

Patients with histologically confirmed, newly diagnosed, localized gastric or gastro-oesophageal adenocarcinoma, that is considered resectable
Patients with clinical stage(T2-3/N(+), T4/N(+/-) :N positive means ≥8 in hour axis)
Signed informed consent

Exclusion criteria:

Age <20 years or ≥76 years Performance status ≥2 in Eastern Cooperative Oncology Group (ECOG) scale
The patients who have the history of other malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix which have been already successfully treated
Previous surgery on neoplasm of stomach
Patients who have not completely recovered from surgery
Distant metastases (M1) to other organs including distant nodal groups (retropancreatic, para-aortic, portal, retroperitoneal, mesenteric node). severe/unstable angina, coronary artery bypass graft, congestive heart failure, transient ischemic attack within 6 months prior to enrollment in the study
Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy, for the currently treated gastric cancer
Patients with active active infection or sepsis
Intolerance of oral taking or malabsorption: lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of TS-1. Ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug resorption. This includes gastric dumping syndrome, indications of accelerated passage through the small intestine and indications of resorption disorders after intestinal surgery
≥ grade 2 severe tumour haemorrhage
Simultaneous participation in another study, or participation in another study within 4 weeks of commencement of this study
Pregnant or lactating patients

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Information from the National Library of Medicine

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): NCT01515748

Locations


Korea, Republic of
Administrative Office
Seoul, Korea, Republic of

Sponsors and Collaborators

Sanofi

Investigators


Principal Investigator:	Yoon-Koo KANG, MD, PhD	Asan Medical Center

More Information


Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT01515748 History of Changes
Other Study ID Numbers:	DOCET_R_05153 U1111-1127-0246 ( Other Identifier: UTN )
First Submitted:	January 10, 2012
First Posted:	January 24, 2012
Last Update Posted:	April 13, 2017
Last Verified:	April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Additional relevant MeSH terms:


Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Docetaxel Oxaliplatin Fluorouracil	Tegafur Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs

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