Back to resultsAdjuvant Treatment of Gastric Cancer With Chemotherapy and Chemoradiotherapy (TRACE) (TRACE)
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
association chemotherapy and radiochemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility 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
Sites / Locations
- University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Preoperative chemoradiotherapy
Postoperative chemoradiotherapy
Arm Description
Outcomes
Primary Outcome Measures
feasibility of treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT00512304
First Posted
August 6, 2007
Last Updated
March 4, 2013
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT00512304
Brief Title
Adjuvant Treatment of Gastric Cancer With Chemotherapy and Chemoradiotherapy (TRACE)
Acronym
TRACE
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 Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preoperative chemoradiotherapy
Arm Type
Experimental
Arm Title
Postoperative chemoradiotherapy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
association chemotherapy and radiochemotherapy
Primary Outcome Measure Information:
Title
feasibility of treatment
Time Frame
at the end of the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MICHEL Pierre, MD
Organizational Affiliation
University Hospital, Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
Learn more about this trial
Adjuvant Treatment of Gastric Cancer With Chemotherapy and Chemoradiotherapy (TRACE)
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