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| ID | Type | Description | Link |
|---|---|---|---|
| CEPAFIRI |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
| Sanofi-Synthelabo | INDUSTRY |
| Aventis Pharmaceuticals | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irinotecan associated to fluorouracil and leucovorin | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan associated to fluorouracil and leucovorin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.). | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of inclusion until the date of date of death from any cause, assessed up to 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne FONCK, MD | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Bordeaux | Bordeaux | 33076 | France | |||
| Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21907007 | Result | Fonck M, Brunet R, Becouarn Y, Legoux JL, Dauba J, Cany L, Smith D, Auby D, Terrebonne E, Traissac L, Mertens C, Soubeyran P, Bellera C, Rainfray M, Mathoulin-Pelissier S. Evaluation of efficacy and safety of FOLFIRI for elderly patients with gastric cancer: a first-line phase II study. Clin Res Hepatol Gastroenterol. 2011 Dec;35(12):823-30. doi: 10.1016/j.clinre.2011.08.002. Epub 2011 Sep 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. | 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 |
| Bordeaux |
| 33076 |
| France |
| Hopital Robert Boulin | Libourne | 33700 | France |
| Centre Hospitalier Universitaire de Pau | Pau | 64000 | France |
| Clinique Francheville | Périgueux | 24000 | France |
| Centre Hospitalier Universitaire de Villeneuve sur Lot | Villeneuve-sur-Lot | 47000 | France |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.). | The medical record was lost for 2 patients: no radiologial and clinical data is available | Posted | Number | 95% Confidence Interval | percentage of participants | 2 months |
|
|
| |||||||||||||||||||||||||
| 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. | The medical record was lost for 2 patients: no radiologial and clinical data is available. | Posted | Median | 95% Confidence Interval | months | From date of inclusion until the date of date of death from any cause, assessed up to 12 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. | The medical record was lost for 2 patients: no radiologial and clinical data is available. | Posted | Median | 95% Confidence Interval | months | 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 |
|
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Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 35 | 41 | 16 | 41 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric hemorrhage | Gastrointestinal disorders | CTCAE V5.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | CTCAE V5.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE V5.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE V5.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE V5.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | CTCAE V5.0 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE V5.0 | Systematic Assessment |
| |
| Perocarditis | Cardiac disorders | CTCAE V5.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE V5.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE V5.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE V5.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE V5.0 | Systematic Assessment |
| |
| General disorders and administration site conditions - other specify | General disorders | CTCAE V5.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE V5.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | CTCAE V5.0 | Systematic Assessment |
| |
| Peritoneal infection | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Marianne Fonck | Institut Bergonie | +33556333333 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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| Units | Counts |
|---|---|
| Participants |
|
|