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)

March 30, 2023 updated by: Rennes University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

490

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix en Provence, France
        • CH du Pays D'Aix
      • Amiens, France
        • CHU Amien Picardie
      • Angers, France
        • Centre Hospitalier Universitaire d'Angers
      • Annecy, France
        • Centre Hospitalier d'Annecy
      • Antibes, France
        • Centre Hospitalier Général de la Fontonne Antibes
      • Bastia, France
        • CH de Bastia
      • Beauvais, France
        • Centre Hospitalier de Beauvais
      • Bordeaux Pessac, France
        • CHU Bordeaux Hôpital Haut Lévèque
      • Brest, France
        • Centre Hospitalier Universaitaire de Brest
      • Brest, France
        • HIA Tonnerre
      • Caen, France
        • Centre Francois Baclesse
      • Cergy Pontoise, France
        • Ch Rene Dubos - Pontoise
      • Charleville Mézières, France
        • Centre Hospitalier Charleville mézières
      • Créteil, France
        • CHI créteil
      • Draguignan, France
        • Centre Hospitalier de Draguignan
      • Elbeuf, France
        • Centre Hospitalier de Elbeuf
      • Gap, France
        • CH Gap
      • La Roche sur Yon, France
        • CH La Roche sur Yon
      • Le Chesnay, France
        • Hôpital A Mignot Le Chesnay
      • Lille, France
        • Centre Omar Lambret
      • Limoges, France
        • Hôpital du Cluzeau
      • Longjumeau, France
        • CHR Longjumeau
      • Lorient, France
        • Centre Hospitalier de Bretagne Sud
      • Lyon, France
        • Hôpital de La Croix Rousse
      • Mantes La Jolie, France
        • Centre hospitalier
      • Marseille, France
        • Hôpital Sainte Marguerite
      • Marseille, France
        • Institut Paoli-Calmette
      • Martigues, France
        • Centre hospitalier
      • Meaux, France
        • Hôpital Saint Farron
      • Mulhouse, France
        • Centre Hospitalier de Mulhouse
      • Orléans, France
        • CHR Orléans
      • Paris, France
        • Paris Hôpital saint Antoine
      • Perpignan, France
        • Centre Catalan
      • Périgueux, France
        • Centre Hospitalier de Périgueux
      • Rennes, France, 35033
        • Rennes Hospital University
      • Rouen, France
        • CHU Rouen Hôpital Boisguillaume
      • Rouen, France
        • Hôpital Charles Nicolle
      • Saint Etienne, France
        • CHU Saint Etienne - Hôpital Nord
      • Salon de Provence, France
        • Centre Hospitalier Général Salon de Provence
      • St Priest en Jarez, France
        • Institut de Cancerologie de La Loire
      • Toulon, France
        • Hôpital Font-Pre
      • Toulon Naval, France
        • Hopital D'Instruction Des Armees
      • Toulouse, France
        • CHU Touloues
      • Villefranche sur Saone, France
        • Centre Hospitalier de Villefranche sur Saone
      • saint Brieuc, France
        • Hôpital Yves Le Foll

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: date of documented progression up to 6 months
date of documented progression up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 21, 2010

First Submitted That Met QC Criteria

December 8, 2010

First Posted (Estimate)

December 9, 2010

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2008-008372-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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