Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Irinotecan

Leucovorin

Fluorouracil

Levoleucovorin

Folic Acid

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

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

Irinotecan associated to fluorouracil and leucovorin

Marianne FONCK, MD

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.

Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer

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

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.).

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.

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.

Novartis

Sanofi-Synthelabo

Aventis Pharmaceuticals

Institut Bergonié

Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.

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

Irinotecan Associated to Fluorouracil and Leucovorin

Age, Continuous

Sex: Female, Male

France

Region of Enrollment

Pr Marianne Fonck

The medical record was lost for 2 patients: no radiologial and clinical data is available

2-month Response Rate

The medical record was lost for 2 patients: no radiologial and clinical data is available.

Overall Survival

Progression-free Survival

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

Blood and Lymph Conditions

Immune System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Lymphoma

Lung Diseases

Urinary Bladder Diseases

Prostatic Diseases

Ovarian Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Genital Diseases

Genital Diseases, Male

Adnexal Diseases

Genital Diseases, Female

Gonadal Disorders

Endocrine System Diseases

Lymphosarcoma

Pierre SOUBEYRAN, MD, PhD

Incidence of cancer in 75+ years old is 16,500 new cases per year, more than fifty percent of people with cancerThey are very few therapeutic trials dedicated. Oncologists hesitate to treat them because they are either afraid of inducing toxicity or of breaking down quality of life. Consequently, we decided to launch a protocol with both oncologists and geriatricians which principal aim is to find out if geriatric assessment data can help to better predict for chemotherapy toxicity, loss of autonomy and survival. We plan to accrue 360 patients diagnosed for cancer, including digestive, pulmonary, prostate, lymphoma, bladder, ovary cancer for whom first-line chemotherapy is planned. Patients are initially classified according to usual methods of medical oncology practice into three groups: patients who can receive standard treatment, reduced standard treatment or treatment adapted to the frail condition. Around Aquitaine, , we organised seven teams composed of one geriatrician and one nurse. Two kind of teams were activated: one which cover ten treatment sites in Bordeaux area and six sedentary teams which worked half a day a week in designated hospitals . Geriatric evaluation included test 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. Patients have four geriatric evaluations : before treatment, day 1 cycle 2, day 1 cycle 4, day 1 cycle 7 and/or end of chemotherapy. Since September 2002, 177 patients have been included, 112 have finished: 47.3% have received four evaluations, 16.1% died before the end of protocol, 14.3% stopped because they were in progression and changed their treatment, 11.6% met administrative problem that didn't allow all evaluations, 7.1% declined after inclusion and 3.6% finished their treatment before. The following results have been obtained: before treatment, 73% of these patients were at risk of undernutrition (MNA\< 23.5), about 1/3 had one or more inability or a risk of falls (38% IADL\<6, 29% get up and go\>20seconds, 27% ADL\>1, 34% PS\<1), 28% of them had altered cognitive functions (MMS\<24), 29% were depressive (GDS-15\>6), 25% thought they had poor quality of life (QLQ-C30\<4). Protocol will be closed in September 2005.

Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment

Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment . Geriatric Oncology Protocol in Aquitaine Country.

Number of participant deaths observed during the course of the study

Amgen

Chugai Pharmaceutical

Bristol-Myers Squibb

Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.

Eligible Patients

Pr Simone Mathoulin-Pélissier

Eleven patients did not complete the geriatric evaluation, and an additional five patients were lost to follow-up before 6 months, which left 348 analyzed patients

Number of Participant Deaths

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer	NCT00210184	Gastric Cancer	Irinotecan asso...	70 Years - 100 Years	Institut Bergonié
Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment	NCT00210249	Lymphoma Digestive Syste... Ovarian Disease... Pulmonary Disea... Prostatic Disea... Bladder Disease		70 Years -	Institut Bergonié
Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment	NCT00210249	Lymphoma Digestive Syste... Ovarian Disease... Pulmonary Disea... Prostatic Disea... Bladder Disease		70 Years -	Institut Bergonié

Spots Global Cancer Trial Database for geriatric evaluation