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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:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01515748
First received: January 10, 2012
Last updated: April 12, 2017
Last verified: April 2017
  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: No masking
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:


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 )
Study First Received: January 10, 2012
Last Updated: April 12, 2017
Individual Participant Data  
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
Oxaliplatin
Docetaxel
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

ClinicalTrials.gov processed this record on June 23, 2017