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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC OncoG | Other Identifier | Institut BergoniƩ |
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| Name | Class |
|---|---|
| Sanofi-Synthelabo | INDUSTRY |
| Aventis Pharmaceuticals | INDUSTRY |
| Amgen | INDUSTRY |
| Chugai Pharmaceutical |
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participant Deaths | Number of participant deaths observed during the course of the study | 6 months after inclusion |
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Inclusion criteria:
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Patients greater than 70 year of age (no upper age limit) who were scheduled to receive first-line chemotherapy for various types of cancer (ie, colon, pancreas, stomach, ovary, bladder, prostate, lung cancer, non-Hodgkin's lymphoma [NHL], or cancer of unknown primary origin), excluding breast cancer, were eligible for inclusion. Patients with known CNS metastases were excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Pierre SOUBEYRAN, MD, PhD | Institut BergoniƩ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de radiothƩrapie d'Agen | Agen | 47000 | France | |||
| Centre Hospitalier Universitaire d'Agen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22508806 | Result | Soubeyran P, Fonck M, Blanc-Bisson C, Blanc JF, Ceccaldi J, Mertens C, Imbert Y, Cany L, Vogt L, Dauba J, Andriamampionona F, Houede N, Floquet A, Chomy F, Brouste V, Ravaud A, Bellera C, Rainfray M. Predictors of early death risk in older patients treated with first-line chemotherapy for cancer. J Clin Oncol. 2012 May 20;30(15):1829-34. doi: 10.1200/JCO.2011.35.7442. Epub 2012 Apr 16. | |
| 24062399 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eligible Patients | Patients satisfying eligibility criteria |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| INDUSTRY |
| Bristol-Myers Squibb | INDUSTRY |
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| Agen |
| 47000 |
| France |
| Clinique Esquirol Saint Hilaire | Agen | 47000 | France |
| Centre Hospitalier Universitaire de Bayonne | Bayonne | 64000 | France |
| Centre Hospitalier de la CƓte Basque | Bayonne | 64100 | France |
| Clinique Saint Etienne du Pays Basque | Bayonne | 64100 | France |
| Clinique Tivoli | Bordeaux | 33000 | France |
| Centre Hospitalier Universitaire de Bordeaux | Bordeaux | 33076 | France |
| Institut BergoniƩ - Centre RƩgional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest | Bordeaux | 33076 | France |
| Centre Hospitalier Universitaire de Dax | Dax | 40100 | France |
| Hopital Sub-Urbain du Bouscat | Le Bouscat | 33110 | France |
| HƓpital Robert Boulin | Libourne | 33500 | France |
| Centre Hospitalier Universitaire de Mont de Marsan | Mont-de-Marsan | 40000 | France |
| Centre Hospitalier Universitaire de Pau | Pau | 64000 | France |
| Centre Hospitalier Universitaire de Perigueux | PƩrigueux | 24000 | France |
| Clinique Francheville | PƩrigueux | 24000 | France |
| Maison de SantƩ Protestante Bagatelle | Talence | 33400 | France |
| Centre Hospitalier Universitaire de Villeneuve sur Lot | Villeneuve-sur-Lot | 47000 | France |
| Derived |
| Hoppe S, Rainfray M, Fonck M, Hoppenreys L, Blanc JF, Ceccaldi J, Mertens C, Blanc-Bisson C, Imbert Y, Cany L, Vogt L, Dauba J, Houede N, Bellera CA, Floquet A, Fabry MN, Ravaud A, Chakiba C, Mathoulin-Pelissier S, Soubeyran P. Functional decline in older patients with cancer receiving first-line chemotherapy. J Clin Oncol. 2013 Nov 1;31(31):3877-82. doi: 10.1200/JCO.2012.47.7430. Epub 2013 Sep 23. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Eligible Patients | Patients satisfying eligibility criteria |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Number of Participant Deaths | Number of participant deaths observed during the course of the study | 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 | Posted | Count of Participants | Participants | 6 months after inclusion |
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Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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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 | Eligible Patients | Patients satisfying eligibility criteria | 56 | 348 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Simone Mathoulin-PƩlissier | Institut BergoniƩ, Comprehensive Cancer Center, Bordeaux, FR | +33 (0)5 56 33 33 33 | s.mathoulin@bordeaux.unicancer.fr |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D004066 | Digestive System Diseases |
| D010049 | Ovarian Diseases |
| D008171 | Lung Diseases |
| D011469 | Prostatic Diseases |
| D001745 | Urinary Bladder Diseases |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D012140 | Respiratory Tract Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic Diseases |
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