Gastric Cancer
Conditions
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.
Interventions
PROCEDUREassociation chemotherapy and radiochemotherapy
Sponsors
University Hospital, Rouen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility of treatment | at the end of the treatment |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMICHEL Pierre, MD
University Hospital, Rouen
Outcome results
None listed