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

Non Small-cell Lung Cancer Clinical Trial

— ESOGIA  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257139
• Other study ID #: EudraCT 2008-008372-13
• Status: Completed
• Phase: Phase 3
• Start date: January 2010
• Est. completion date: July 2014

Study information

• Verified date: March 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Contraindication to the study drugs.

• Concurrent participation in another clinical trial

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small-cell Lung Cancer

Intervention

Procedure:
• Dual-agent therapy or docetaxel alone or best supportive care
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.

Locations

Country	Name	City	State
France	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 Hospitalier de Périgueux	Périgueux
France	Centre Catalan	Perpignan
France	Rennes Hospital University	Rennes
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	Centre Hospitalier Général Salon de Provence	Salon de Provence
France	Institut de Cancérologie de la Loire	St Priest en Jarez
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 Saone

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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