Trial Involving Subjects Over 70 Years of Age With Non Small-cell Lung Cancer of Stage IV and Comparing a "Classical" Strategy of Treatment Allocation, With an"Optimized" Strategy Allocating the Same Treatments
ESOGIA
1 other identifier
interventional
490
1 country
45
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2010
Typical duration for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 21, 2010
CompletedFirst Posted
Study publicly available on registry
December 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedApril 3, 2023
March 1, 2023
4.5 years
January 21, 2010
March 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
dual-agent therapy or docetaxel alone
NO INTERVENTIONdual-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
EXPERIMENTALdual-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
Interventions
ARM B: (245 patients) Treatment if the SGS screening test is negative: * non epidermoid tumor: * Carboplatin ® AUC 5 on D1 and Alimta ®(pemetrexed) 500 mg/m² D1, D1=D21 with vitamin B9 and B12 supplementation. Maximum of four 3-week cycles. * epidermoid tumor: * Carboplatin AUC 5 on D1 and Gemcitabin 1000 mg/m² on D1 and D8, D1=D21. Treatment if SGS screening test is positive (cf.table 1): Vulnerable subjects will receive: Taxotere ® (Docetaxel) 38 mg/m² on D1 and D8, D1=D21. Maximum of four 3-week cycles Fragile subjects are patients considered to be at a high risk of complications during chemotherapy; they will therefore receive best supportive care (BSC) with appropriate geriatric management.
Eligibility Criteria
You may qualify if:
- Cytologically or histologically proven NSCLC(adenocarcinoma, epidermoid carcinoma, large-cell carcinoma) of stage IV with histologically or cytologically proven pleurisy or neoplastic pericarditis.
- No previous systemic chemotherapy for lung cancer.
- Presence of at least one measurable target lesion (RECIST rules) in a non irradiated region.
- Age strictly at least 70 years.
- PS 0, 1 or 2.
- Life expectancy sup 12 weeks.
- Creatinine clearance at least 45 ml per min with MDRD Formula (Modification in the Diet in Renal Disease).
- Normal hematologic function: absolute polymorphonuclear neutrophil count \> 1.5 . 109 per l and or platelets sup 100 . 109/l, hemoglobin sup 9.5 g per dl
- Normal hepatic function: bilirubin inf 1.5 x normal, SGOT and SGPT inf 2.5 . normal.
- Patients with metastatic relapse (cytologically or histologically proven) of primary lung cancer in a non irradiated region, after surgical excision or local external radiotherapy.
- Prior irradiation is authorized if it involved less than 25 percent of the total bone marrow volume.
- Men must be surgically sterile or must accept the use of an effective contraceptive methodall along and until 6 months after the treatment period
- Signed written informed consent.
You may not qualify if:
- Other severe concurrent disorders that occurred during the prior six months before enrollment (myocardial infection, severe or unstable angor, coronarian or peripheric arterial bypass operation, NYHA class 3 or 4 congestive heart failure, transient or constituted cerebral ischemic attack, at least grade 2 peripheral neuropathy, stomach ulcer, erosive oesophagitis or gastritis, psychiatric or neurological disorders preventing the patient from understanding the trial, uncontrolled infections).
- Another previous or concomitant cancer, except for basocellular cancer of the skin or treated cervical cancer in situ, or appropriately treated localized lowgrade prostate cancer (Gleason score inf 6), unless the initial tumor was diagnosed and definitively treated more than 5 years previously, with no evidence of relapse.
- Bronchoalveolar or neuroendocrine or composite cancers
- Superior caval syndrome.
- Presence of symptomatic brain metastases.
- Peripheral neuropathies (grade sup 2).
- Performance status sup 2 (ECOG).
- A significant third liquid part (for example ascitis or pleural effusion) hat can't be controlled with drainage or other procedures before enrollment
- Impossibility to stop a treatment by aspirin (if the dose is more than 1.3 mg per day) or NSAI during 5 days (8 days for molecules with long period action like piroxicam
- Concurrent participation in another clinical trial.
- Definitive contraindication to steroids or folic acid and vitamin B12 if histology is non-epidermoid.
- All concurrent radiotherapy, except for local palliative bone radiotherapy.
- Concurrent administration of one or several other antitumor therapies. Recent vaccination for yellow fever (during the 30 days before enrollment)
- Psychological, familial, social or geographic difficulties preventing follow-up as defined by the protocol.
- Administrative or legal detention.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
CH du Pays d'Aix
Aix-en-Provence, France
CHU Amien Picardie
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
Related Publications (1)
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.
PMID: 26884557RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2010
First Posted
December 9, 2010
Study Start
January 1, 2010
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
April 3, 2023
Record last verified: 2023-03