Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210184
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2005-09-13
Brief Title:
Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer
Sponsor:
Institut Bergonié
Organization:
Institut Bergonié
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CEPAFIRI
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CEPAFIRI | None | None | None |