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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01257139
First received: January 21, 2010
Last updated: April 1, 2015
Last verified: April 2015
  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 ]

Enrollment: 490
Study Start Date: January 2010
Study Completion Date: July 2014
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

Locations
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 Catalan
Perpignan, France
Centre Hospitalier de Périgueux
Périgueux, France
Rennes Hospital University
Rennes, France, 35033
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, France
Sponsors and Collaborators
Rennes University Hospital
  More Information

No publications provided

Responsible Party: 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: April 1, 2015
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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
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 September 02, 2015