Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer (CEPAFIRI)
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Purpose
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 subjects of the same age. Physicians hesitate to treat them with optimal doses because they are afraid of the risk of toxicity in spite of the benefits of treatment. Fifty eight percent of gastric cancers are diagnosed in patients over the age of 70 in France. FOLFIRI (irinotecan, leucovorin and fluorouracil) chemotherapy appears to be a promising treatment for digestive cancer. It increases the level of response and survival without major toxicity. It becomes necessary to evaluate patients, to propose adapted treatments for their conditions.
The principal objectives are to demonstrate the efficacy of treatment, safety, survival and to find out if geriatric assessment data can help to better predict chemotherapy toxicity. The researchers plan to accrue 43 patients diagnosed with locally advanced or metastatic gastric cancer. They will receive FOLFIRI and 4 geriatric evaluations: before treatment, day 1 cycle 2, day 1 cycle 4 and at the end of chemotherapy. These evaluations include tests of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL; IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: Irinotecan associated to fluorouracil and leucovorin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest | |
| Bordeaux, France, 33076 | |
| Centre Hospitalier Universitaire de Bordeaux | |
| Bordeaux, France, 33076 | |
| Hopital Robert Boulin | |
| Libourne, France, 33700 | |
| Centre Hospitalier Universitaire de Pau | |
| Pau, France, 64000 | |
| Clinique Francheville | |
| Perigueux, France, 24000 | |
| Centre Hospitalier Universitaire de Villeneuve sur Lot | |
| Villeneuve sur Lot, France, 47000 | |
| Principal Investigator: | Marianne FONCK, MD | Institut Bergonié |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00210184 History of Changes |
| Other Study ID Numbers: | IB2004-18, CEPAFIRI |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 29, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Institut Bergonié:
|
Chemotherapy gastric cancer geriatric evaluation efficacy safety |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Fluorouracil Irinotecan Leucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013