Gastric Cancer
Conditions
Keywords
Chemotherapy, gastric cancer, geriatric evaluation, efficacy, safety
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.
Interventions
DRUGIrinotecan associated to fluorouracil and leucovorin
Sponsors
Novartis
Sanofi-Synthelabo
Aventis Pharmaceuticals
Institut Bergonié
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-month Response Rate | 2 months | Response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0. Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of inclusion until the date of date of death from any cause, assessed up to 12 months. | OS was defined as the time from trial inclusion to death due to any cause. Participants without documented death were censored at the date of the last follow-up or last patient contact. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. |
| Progression-free Survival | From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months | PFS was defined as time since trial inclusion to progression or death from any cause, whichever occurred first, and data from patients progression-free and lost to follow-up before the study end were censored at date of last news. The PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Irinotecan Associated to Fluorouracil and Leucovorin On D1, as a single 90-minute intravenous infusion diluted in 250 ml of saline (sodium chloride a 9 ‰), or isotonic glucose, at a dose of 180 mg/m2. Dosage adjustments are provided in case of severe toxicity.
Then 5FU/ folinic acid: 400 mg/m2 of 5-FU as an IV bolus followed by a continuous 2400 mg/m2 infusion over 46 hours with 400 mg/m2 of folinic acid or 200 mg/m2 of l-folinic acid as a 2-hour infusion before 5-FU administration.
Doses of 5-FU are adjusted according to clinical tolerance. Resume on D15 for 6 months
Translated with www.DeepL.com/Translator (free version)
Irinotecan associated to fluorouracil and leucovorin | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | The medical record was lost for these patients: no clinical data is available | 2 |
Baseline characteristics
| Characteristic | Irinotecan Associated to Fluorouracil and Leucovorin |
|---|---|
| Age, Continuous | 77.3 years |
| Region of Enrollment France | 42 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 35 / 41 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 16 / 41 |
Outcome results
Primary
2-month Response Rate
Response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0. Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).
Time frame: 2 months
Population: The medical record was lost for 2 patients: no radiologial and clinical data is available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Irinotecan Associated to Fluorouracil and Leucovorin | 2-month Response Rate | 25 percentage of participants |
Secondary
Overall Survival
OS was defined as the time from trial inclusion to death due to any cause. Participants without documented death were censored at the date of the last follow-up or last patient contact. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Time frame: From date of inclusion until the date of date of death from any cause, assessed up to 12 months.
Population: The medical record was lost for 2 patients: no radiologial and clinical data is available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Irinotecan Associated to Fluorouracil and Leucovorin | Overall Survival | 10 months |
Secondary
Progression-free Survival
PFS was defined as time since trial inclusion to progression or death from any cause, whichever occurred first, and data from patients progression-free and lost to follow-up before the study end were censored at date of last news. The PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Population: The medical record was lost for 2 patients: no radiologial and clinical data is available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Irinotecan Associated to Fluorouracil and Leucovorin | Progression-free Survival | 7 months |