Multicentric Phase II Trial: Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years Old and More Presenting Gastric Cancer Locally Advanced or Metastatic
Phase 2
70 Years
N/A
70 Years
N/A
Not Enrolling
Both
Gastric Cancer
Both
Gastric Cancer
Trial Information
Multicentric Phase II Trial: Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years Old and More Presenting Gastric Cancer Locally Advanced or Metastatic
Inclusion Criteria:
- 70 years of age or older
- Gastric cancer, locally advanced or metastatic
- No previous adjuvant treatment (surgery, radiotherapy, chemotherapy) in the last 6
months
- One measurable lesion
- ECOG < 3
- Biology and biochemistry within normal limits
- Life expectancy > 12 weeks
Exclusion Criteria:
- Other palliative chemotherapy for this cancer
- Other cancer in the last 5 years
- Previous treatment with irinotecan
- Atropine treatment not possible
- Concomitant cancer therapy except bone radiotherapy
- Metastases to brain or meninges with symptoms
- Other severe pathology uncontrolled
- Problem of compliance
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Partial response after 2 months of treatment
Principal Investigator
Marianne FONCK, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Bergonié
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
IB2004-18
NCT ID:
NCT00210184
Start Date:
July 2004
Completion Date:
July 2009
Related Keywords:
- Gastric Cancer
- Chemotherapy
- gastric cancer
- geriatric evaluation
- efficacy
- safety
- Stomach Neoplasms
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