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Adjuvant Treatment of Gastric Cancer With Chemotherapy and Chemoradiotherapy (TRACE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00512304
First received: August 6, 2007
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

Post-operative radio-chemotherapy decrease the recurrence risk of gastric cancer(N Engl J Med 2001). However the chemotherapy regimen (5 fluorouracil IV bolus) used was toxic and suboptimal. We propose to evaluate in adjuvant situation an active and well tolerate chemotherapy regimen (FOLFIRI)in patients with metastatic gastric cancer. During the radiotherapy we will use 5 FU continue infusion as previously reported. The global design of adjuvant treatment will be four FOLFIRI courses, radiotherapy (45 Gy)with 5FU IV continue then four FOLFIRI.


Condition Intervention Phase
Gastric Cancer
 Procedure: association chemotherapy and radiochemotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study of 2 Parallel Phases II Pre or Postgastrectomy in Patients With Gastric Cancer (FOLFIRI-radiotherapy Plus 5 Fluorouracil-surgery or Surgery-FOLFIRI-radiotherapy Plus 5 Fluorouracil)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • feasibility of treatment [ Time Frame: at the end of the treatment ] [ Designated as safety issue: Yes ]

Enrollment: 63
Study Start Date: August 2007
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preoperative chemoradiotherapy Procedure: association chemotherapy and radiochemotherapy
Experimental: Postoperative chemoradiotherapy Procedure: association chemotherapy and radiochemotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gastric adenocarcinoma histologically confirmed
  • tumor T3 or N+ at the pretherapeutic staging (Scanner and endoscopic ultrasound)
  • performance status WHO<2
  • serum albumin >30 gr/l
  • weight loss < 10% in the next 6 months
  • signed informed consent form

Exclusion Criteria:

  • metastatic disease
  • prior abdominal radiotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512304

Locations
France
University hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: MICHEL Pierre, MD University Hospital, Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00512304     History of Changes
Other Study ID Numbers: 2006/097/HP
Study First Received: August 6, 2007
Last Updated: March 4, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 22, 2013