Trial Outcomes & Findings for Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer (NCT NCT00210184)
NCT ID: NCT00210184
Last Updated: 2021-10-06
Results Overview
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.).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
2 months
Results posted on
2021-10-06
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
The medical record was lost for these patients: no clinical data is available
|
2
|
Baseline Characteristics
Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer
Baseline characteristics by cohort
| Measure |
Irinotecan Associated to Fluorouracil and Leucovorin
n=42 Participants
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
|
|---|---|
|
Age, Continuous
|
77.3 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=93 Participants
|
|
Region of Enrollment
France
|
42 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: The medical record was lost for 2 patients: no radiologial and clinical data is available
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.).
Outcome measures
| Measure |
Irinotecan Associated to Fluorouracil and Leucovorin
n=40 Participants
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
|
|---|---|
|
2-month Response Rate
|
25 percentage of participants
Interval 12.7 to 41.2
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Irinotecan Associated to Fluorouracil and Leucovorin
n=40 Participants
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
|
|---|---|
|
Overall Survival
|
10 months
Interval 7.0 to 15.0
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SECONDARY outcome
Timeframe: 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 monthsPopulation: The medical record was lost for 2 patients: no radiologial and clinical data is available.
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.
Outcome measures
| Measure |
Irinotecan Associated to Fluorouracil and Leucovorin
n=40 Participants
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
|
|---|---|
|
Progression-free Survival
|
7 months
Interval 5.0 to 10.0
|
Adverse Events
Irinotecan Associated to Fluorouracil and Leucovorin
Serious events: 16 serious events
Other events: 0 other events
Deaths: 35 deaths
Serious adverse events
| Measure |
Irinotecan Associated to Fluorouracil and Leucovorin
n=41 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.4%
1/41 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
Psychiatric disorders
Suicide attempt
|
2.4%
1/41 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
Investigations
Neutrophil count decreased
|
2.4%
1/41 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
7.3%
3/41 • Number of events 5
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/41 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
Cardiac disorders
Myocardial infarction
|
2.4%
1/41 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/41 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
Cardiac disorders
Perocarditis
|
4.9%
2/41 • Number of events 2
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/41 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
1/41 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/41 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
Nervous system disorders
Seizure
|
2.4%
1/41 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
General disorders
General disorders and administration site conditions - other specify
|
9.8%
4/41 • Number of events 4
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
Infections and infestations
Device related infection
|
2.4%
1/41 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.4%
1/41 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.4%
1/41 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
Gastrointestinal disorders
vomiting
|
2.4%
1/41 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
|
Infections and infestations
Peritoneal infection
|
2.4%
1/41 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Pr Marianne Fonck
Institut Bergonie
Phone: +33556333333
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place