Adjuvant Treatment of Gastric Cancer With Chemotherapy and Chemoradiotherapy (TRACE) (TRACE)
March 25, 2026 updated by: University Hospital, Rouen
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Rouen, France, 76031
- University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Preoperative chemoradiotherapy
|
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Experimental: Postoperative chemoradiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
feasibility of treatment
Time Frame: at the end of the treatment
|
at the end of the treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: MICHEL Pierre, MD, University Hospital, Rouen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
October 31, 2013
Study Registration Dates
First Submitted
August 6, 2007
First Submitted That Met QC Criteria
August 6, 2007
First Posted (Estimated)
August 7, 2007
Study Record Updates
Last Update Posted (Actual)
March 27, 2026
Last Update Submitted That Met QC Criteria
March 25, 2026
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006/097/HP
- 2006-005576-40 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.