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

University Hospital, Rouen

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Procedure: association chemotherapy and radiochemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00512304

2006/097/HP

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Preoperative chemoradiotherapy

Experimental group

Treatment:

Procedure: association chemotherapy and radiochemotherapy

Postoperative chemoradiotherapy

Experimental group

Treatment:

Procedure: association chemotherapy and radiochemotherapy