Status:
COMPLETED
Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer
Lead Sponsor:
Institut Bergonié
Collaborating Sponsors:
Novartis
Sanofi-Synthelabo
Conditions:
Gastric Cancer
Eligibility:
All Genders
70-100 years
Phase:
PHASE2
Brief Summary
The number of patients over 70 years old with cancer is increasing in France. This population is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a lot between ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 21 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00210184
Start Date
July 21 2004
End Date
April 1 2010
Last Update
October 6 2021
Active Locations (6)
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1
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France, 33076
2
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, France, 33076
3
Hopital Robert Boulin
Libourne, France, 33700
4
Centre Hospitalier Universitaire de Pau
Pau, France, 64000