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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Rennes University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01257139
First received: January 21, 2010
Last updated: December 8, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Non Small-cell Lung Cancer
Procedure: Dual-agent therapy or docetaxel alone or best supportive care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • 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 [ Time Frame: date of documented progression up to 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 490
Study Start Date: January 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: dual-agent therapy or docetaxel alone
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
Experimental: dual-agent therapy or docetaxel or best supportive care
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
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257139

Contacts
Contact: Romain Corre, MD romain.corre@chu-rennes.fr

Locations
France
CH du Pays d'Aix Recruiting
Aix en Provence, France
Contact: Poirier         
CHU Amien Picardie Recruiting
Amiens, France
Contact: Géraldine François         
Centre Hospitalier Universitaire d'Angers Recruiting
Angers, France
Contact: Urban Jeanfaivre Hureaux         
Centre Hospitalier d'Annecy Recruiting
Annecy, France
Contact: Hominal         
Centre Hospitalier Général de la Fontonne Antibes Recruiting
Antibes, France
Contact: Chavaillon Kahlout         
CH de Bastia Recruiting
Bastia, France
Contact: Mouries         
Centre Hospitalier de Beauvais Recruiting
Beauvais, France
Contact: Crequit Bouchaert         
CHU Bordeaux Hôpital Haut Lévêque Recruiting
Bordeaux Pessac, France
Contact: Vernejoux         
Centre Hospitalier Universaitaire de Brest Recruiting
Brest, France
Contact: Robinet Gouva         
HIA Tonnerre Recruiting
Brest, France
Contact: Grassin Andre         
Centre François Baclesse Recruiting
Caen, France
Contact: Gervais         
CH René Dubos - Pontoise Recruiting
Cergy Pontoise, France
Contact: Fraboulet         
Centre Hospitalier Charleville mézières Recruiting
Charleville Mézières, France
Contact: Chouabe         
CHI Créteil Recruiting
Créteil, France
Contact: Monnet         
Centre hospitalier de Draguignan Recruiting
Draguignan, France
Contact: Le Caer Barrière         
Centre Hospitalier de Elbeuf Recruiting
Elbeuf, France
Contact: David Vincent         
CH Gap Recruiting
Gap, France
Contact: Thomas         
CH La Roche sur Yon Recruiting
La Roche sur Yon, France
Contact: Bizieux         
Hôpital A Mignot Le Chesnay Recruiting
Le Chesnay, France
Contact: Dujon         
Centre Omar Lambret Recruiting
Lille, France
Contact: Dansin         
Hôpital du Cluzeau Recruiting
Limoges, France
Contact: Vergnenegre         
CHR Longjumeau Recruiting
Longjumeau, France
Contact: Oliviero Assouline         
Centre Hospitalier de Bretagne Sud Recruiting
Lorient, France
Contact: Lamy         
Hôpital de la Croix Rousse Recruiting
Lyon, France
Contact: Arpin         
Centre Hospitalier Recruiting
Mantes La Jolie, France
Contact: Auliac         
Institut Paoli-Calmette Recruiting
Marseille, France
Contact: madroszyk         
Hôpital Sainte Marguerite Recruiting
Marseille, France
Contact: Astoul Gimenez Barlesi         
Centre Hospitalier Recruiting
Martigues, France
Contact: Jullian Simonian         
Hôpital Saint Farron Recruiting
Meaux, France
Contact: Blanchon Grivaux Locher         
Centre Hospitalier de Mulhouse Recruiting
Mulhouse, France
Contact: Bombaron         
CHR Orléans Recruiting
Orléans, France
Contact: Iglesia         
Paris Hôpital saint Antoine Recruiting
Paris, France
Contact: Chouaid Baud         
Centre Catalan Recruiting
Perpignan, France
Contact: Castera         
Centre Hospitalier de Périgueux Recruiting
Périgueux, France
Contact: Delhoume         
Rennes Hospital University Recruiting
Rennes, France, 35033
Contact: Romain Corre, MD    33-2-9928-2478      
Principal Investigator: Romain Corre         
Hôpital Charles Nicolle Recruiting
Rouen, France
Contact: Thiberville Bota         
CHU Rouen Hôpital Boisguillaume Recruiting
Rouen, France
Contact: Paillotin Muir         
Hôpital Yves Le Foll Recruiting
saint Brieuc, France
Contact: Coetmeur         
CHU Saint Etienne - Hôpital Nord Recruiting
Saint Etienne, France
Contact: Bayle         
Centre Hospitalier Général Salon de Provence Recruiting
Salon de Provence, France
Contact: Kasseyet         
Institut de Cancérologie de la Loire Recruiting
St Priest en Jarez, France
Contact: Fournel         
Hôpital Font-Pre Recruiting
Toulon, France
Contact: Audiger-Valette         
Hôpital d'Instruction des Armées Recruiting
Toulon Naval, France
Contact: Berard         
CHU Touloues Recruiting
Toulouse, France
Contact: Mazieres         
Centre Hospitalier De Villefranche sur Saone Recruiting
Villefranche sur Saone, France
Contact: Falchero         
Sponsors and Collaborators
Rennes University Hospital
  More Information

No publications provided

Responsible Party: Direction of Clinical Research, Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01257139     History of Changes
Other Study ID Numbers: EudraCT 2008-008372-13
Study First Received: January 21, 2010
Last Updated: December 8, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
To evaluate a geriatric scale designed to help with treatment
allocation to dual-agent therapy based on platinum or to
single-agent chemotherapy in elderly subjects with advancedstage
NSCLC, based on the time to failure in the two arms

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014