Adjuvant Treatment of Gastric Cancer With Chemotherapy and Chemoradiotherapy (TRACE)
Phase 2
Completed
- Conditions
- Gastric Cancer
- Interventions
- Procedure: association chemotherapy and radiochemotherapy
- Registration Number
- NCT00512304
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Preoperative chemoradiotherapy association chemotherapy and radiochemotherapy - Postoperative chemoradiotherapy association chemotherapy and radiochemotherapy -
- Primary Outcome Measures
Name Time Method feasibility of treatment at the end of the treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University hospital
🇫🇷Rouen, France