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Non Small-cell Lung CancerPhase 3ESOGIANCT01257139

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

A Phase 3 study of Non Small-cell Lung Cancer, run by Rennes University Hospital at 45 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Non Small-cell Lung Cancer
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
490 participants
Where
45 sitesFrance
Study dates
Jan 2010to Jul 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

France45 sites

  • CH du Pays d'Aix

    Aix-en-Provence

  • CHU Amien Picardie

    Amiens

  • Centre Hospitalier Universitaire d'Angers

    Angers

  • Centre Hospitalier d'Annecy

    Annecy

  • Centre Hospitalier Général de la Fontonne Antibes

    Antibes

  • CH de Bastia

    Bastia

  • Centre Hospitalier de Beauvais

    Beauvais

  • CHU Bordeaux Hôpital Haut Lévêque

    Bordeaux Pessac

  • Centre Hospitalier Universaitaire de Brest

    Brest

  • HIA Tonnerre

    Brest

  • Centre François Baclesse

    Caen

  • CH René Dubos - Pontoise

    Cergy-Pontoise

  • Centre Hospitalier Charleville mézières

    Charleville-Mézières

  • CHI Créteil

    Créteil

  • Centre hospitalier de Draguignan

    Draguignan

  • Centre Hospitalier de Elbeuf

    Elbeuf

  • CH Gap

    Gap

  • CH La Roche sur Yon

    La Roche-sur-Yon

  • Hôpital A Mignot Le Chesnay

    Le Chesnay

  • Centre Omar Lambret

    Lille

  • Hôpital du Cluzeau

    Limoges

  • CHR Longjumeau

    Longjumeau

  • Centre Hospitalier de Bretagne Sud

    Lorient

  • Hôpital de la Croix Rousse

    Lyon

  • Centre Hospitalier

    Mantes-la-Jolie

  • Hôpital Sainte Marguerite

    Marseille

  • Institut Paoli-Calmette

    Marseille

  • Centre Hospitalier

    Martigues

  • Hôpital Saint Farron

    Meaux

  • Centre Hospitalier de Mulhouse

    Mulhouse

  • CHR Orléans

    Orléans

  • Paris Hôpital saint Antoine

    Paris

  • Centre Hospitalier de Périgueux

    Périgueux

  • Centre Catalan

    Perpignan

  • Rennes Hospital University

    Rennes, 35033

  • CHU Rouen Hôpital Boisguillaume

    Rouen

  • Hôpital Charles Nicolle

    Rouen

  • Hôpital Yves Le Foll

    Saint-Brieuc

  • CHU Saint Etienne - Hôpital Nord

    Saint-Etienne

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez

  • Centre Hospitalier Général Salon de Provence

    Salon-de-Provence

  • Hôpital Font-Pre

    Toulon

  • Hôpital d'Instruction des Armées

    Toulon Naval

  • CHU Touloues

    Toulouse

  • Centre Hospitalier De Villefranche sur Saone

    Villefranche-sur-Saône

Other trials in France

About this study

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.

Being tested
Dual-agent therapy or docetaxel alone or best supportive care
Keywords
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
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dual-agent therapy or docetaxel alone or best supportive careProcedure or surgery

    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.
Study groups in NCT01257139
Study groupRoleWhat they receive
dual-agent therapy or docetaxel aloneNo 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 careExperimentaldual-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
Receives: Procedure: Dual-agent therapy or docetaxel alone or best supportive care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: date of documented progression up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
490 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01257139
Sponsor's protocol ID
EudraCT 2008-008372-13
Acronym
ESOGIA
Status last verified
Mar 2023
First submitted
21 Jan 2010
Last updated
3 Apr 2023
Results posted
No

Publications

  • 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.

    PubMed 26884557

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Non Small-cell Lung Cancer, run by Rennes University Hospital at 45 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01257139, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.

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