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

This study is not yet open for participant recruitment.

Verified by University Hospital, Rouen, August 2007

Sponsored by:	University Hospital, Rouen
Information provided by:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00512304

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 II

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment
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)

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:

feasibility of treatment

Study Start Date:

August 2007

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

Contacts

Contact: MICHEL Pierre, MD

pierre.michel@chu-rouen.fr

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator:

MICHEL Pierre, MD

University Hospital, Rouen

More Information

Study ID Numbers:	2006/097/HP
Study First Received:	August 6, 2007
Last Updated:	August 6, 2007
ClinicalTrials.gov Identifier:	NCT00512304
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases

Fluorouracil
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009