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

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. Identifier: NCT00512304
Recruitment Status : Completed
First Posted : August 7, 2007
Last Update Posted : March 5, 2013
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:
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 or disease Intervention/treatment Phase
Gastric Cancer Procedure: association chemotherapy and radiochemotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : August 2007
Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Preoperative chemoradiotherapy Procedure: association chemotherapy and radiochemotherapy
Experimental: Postoperative chemoradiotherapy Procedure: association chemotherapy and radiochemotherapy

Primary Outcome Measures :
  1. feasibility of treatment [ Time Frame: at the end of the treatment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00512304

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

Responsible Party: University Hospital, Rouen Identifier: NCT00512304     History of Changes
Other Study ID Numbers: 2006/097/HP
First Posted: August 7, 2007    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases