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

This study is currently recruiting participants.
Verified October 2012 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01515748
First received: January 10, 2012
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Up to a maximum of 5 years ] [ Designated as safety issue: No ]
  • Stage distribution in both groups assessed after surgery [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • RO resection rate [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: Up to a maximum of 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 640
Study Start Date: January 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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 short 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515748

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi-aventis.com

Locations
Korea, Republic of
Administrative Office Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Yoon-Koo KANG, MD, PhD Asan Medical Center
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01515748     History of Changes
Other Study ID Numbers: DOCET_R_05153
Study First Received: January 10, 2012
Last Updated: October 31, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Adjuvants, Immunologic
Fluorouracil
Tegafur
 Oxaliplatin
Docetaxel
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 19, 2013