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This is a phase III randomized multicenter study involving subjects over 70 years of age with non small-cell lung cancer of IV and a PS of 0, 1 or 2, who have not previously received chemotherapy. The aim is to validate the use of a simplified geriatric scale (SGS) as a screening tool. If the SGS results are normal, the patient will be treated with dual-agent therapy based on platinum (carboplatin + pemetrexed if the histology is non epidermoid, carboplatin + gemcitabin if the histology is epidermoid), with no further geriatric assessment. When the SGS reveals abnormalities, a comprehensive geriatric evaluation (CGE) will be used to define two subpopulations on Balducci's fragility scale, who will receive either monotherapy (docetaxel) or best supportive care.
The strategy based on the SGS will be compared with a treatment algorithm based on standard criteria (PS and age), with no specific geriatric assessment. The main endpoint is the time to treatment failure. The SGS is composed of the Charlson co-morbidity scale, functional assessment based on PS, Katz' ADL scale, Lawton's simplified IADL scale, simplified cognitive assessment with the mini-MMSE according to Schultz-Larsen, a geriatric depression scale (GDS 5), and screening for a geriatric syndrome defined by the existence of dementia, repeated falls, and urinary and fecal incontinence. The SGS will be validated by comparison with the CGE, that will be administered systematically at enrollment. All the SGS items are included in the CGE.
Secondary endpoints will be quality of life (measured with the LCSS and EuroQoL questionnaires), overall survival, the objective response rate, and toxicity. The investigators will also study the predictive power of nutritional indices such as the PINI and the Buzby score with respect to survival, the treatment response, and tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dual-agent therapy or docetaxel alone | No Intervention | dual-agent therapy based on Carboplatin (Carboplatin-Pemetrexed for non epidermoid forms, Carboplatin-Gemcitabin for epidermoid forms) or Docetaxel alone, according to PS or age | |
| dual-agent therapy or docetaxel or best supportive care | Experimental | dual-agent therapy based on Carboplatin (Carboplatin-Pemetrexed for non epidermoid forms, Carboplatin-Gemcitabin for epidermoid forms) or Docetaxel alone, or best supportive care, allocated on the basis of a simplified geriatric scale, plus a more thorough geriatric evaluation if necessary |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-agent therapy or docetaxel alone or best supportive care | Procedure | ARM B: (245 patients) Treatment if the SGS screening test is negative:
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to failure Defined from the date of inclusion to the date of documented progression Or death of any cause Or trial exit for toxicity considered unacceptable by the patient or by the investigator Or withdrawal of consent | date of documented progression up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH du Pays d'Aix | Aix-en-Provence | France | ||||
| CHU Amien Picardie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26884557 | Result | Corre R, Greillier L, Le Caer H, Audigier-Valette C, Baize N, Berard H, Falchero L, Monnet I, Dansin E, Vergnenegre A, Marcq M, Decroisette C, Auliac JB, Bota S, Lamy R, Massuti B, Dujon C, Perol M, Daures JP, Descourt R, Lena H, Plassot C, Chouaid C. Use of a Comprehensive Geriatric Assessment for the Management of Elderly Patients With Advanced Non-Small-Cell Lung Cancer: The Phase III Randomized ESOGIA-GFPC-GECP 08-02 Study. J Clin Oncol. 2016 May 1;34(13):1476-83. doi: 10.1200/JCO.2015.63.5839. Epub 2016 Feb 16. |
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|
| Amiens |
| France |
| Centre Hospitalier Universitaire d'Angers | Angers | France |
| Centre Hospitalier d'Annecy | Annecy | France |
| Centre Hospitalier Général de la Fontonne Antibes | Antibes | France |
| CH de Bastia | Bastia | France |
| Centre Hospitalier de Beauvais | Beauvais | France |
| CHU Bordeaux Hôpital Haut Lévêque | Bordeaux Pessac | France |
| Centre Hospitalier Universaitaire de Brest | Brest | France |
| HIA Tonnerre | Brest | France |
| Centre François Baclesse | Caen | France |
| CH René Dubos - Pontoise | Cergy-Pontoise | France |
| Centre Hospitalier Charleville mézières | Charleville-Mézières | France |
| CHI Créteil | Créteil | France |
| Centre hospitalier de Draguignan | Draguignan | France |
| Centre Hospitalier de Elbeuf | Elbeuf | France |
| CH Gap | Gap | France |
| CH La Roche sur Yon | La Roche-sur-Yon | France |
| Hôpital A Mignot Le Chesnay | Le Chesnay | France |
| Centre Omar Lambret | Lille | France |
| Hôpital du Cluzeau | Limoges | France |
| CHR Longjumeau | Longjumeau | France |
| Centre Hospitalier de Bretagne Sud | Lorient | France |
| Hôpital de la Croix Rousse | Lyon | France |
| Centre Hospitalier | Mantes-la-Jolie | France |
| Hôpital Sainte Marguerite | Marseille | France |
| Institut Paoli-Calmette | Marseille | France |
| Centre Hospitalier | Martigues | France |
| Hôpital Saint Farron | Meaux | France |
| Centre Hospitalier de Mulhouse | Mulhouse | France |
| CHR Orléans | Orléans | France |
| Paris Hôpital saint Antoine | Paris | France |
| Centre Catalan | Perpignan | France |
| Centre Hospitalier de Périgueux | Périgueux | France |
| Rennes Hospital University | Rennes | 35033 | France |
| CHU Rouen Hôpital Boisguillaume | Rouen | France |
| Hôpital Charles Nicolle | Rouen | France |
| Hôpital Yves Le Foll | Saint-Brieuc | France |
| CHU Saint Etienne - Hôpital Nord | Saint-Etienne | France |
| Institut de Cancérologie de la Loire | Saint-Priest-en-Jarez | France |
| Centre Hospitalier Général Salon de Provence | Salon-de-Provence | France |
| Hôpital Font-Pre | Toulon | France |
| Hôpital d'Instruction des Armées | Toulon Naval | France |
| CHU Touloues | Toulouse | France |
| Centre Hospitalier De Villefranche sur Saone | Villefranche-sur-Saône | France |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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