Trials / Completed
CompletedNCT00512304
Adjuvant Treatment of Gastric Cancer With Chemotherapy and Chemoradiotherapy (TRACE)
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- University Hospital, Rouen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | association chemotherapy and radiochemotherapy |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2012-12-01
- Completion
- 2013-10-31
- First posted
- 2007-08-07
- Last updated
- 2026-03-27
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00512304. Inclusion in this directory is not an endorsement.