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

University Hospital, Rouen63 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastric Cancer

Interventions

association chemotherapy and radiochemotherapyPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University hospital

Rouen, France

Outcomes

Primary Outcomes

feasibility of treatment

Time frame: at the end of the treatment

Data from ClinicalTrials.gov

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