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 is currently recruiting participants.
Verified December 2010 by Rennes University Hospital
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

January 21, 2010
December 8, 2010
January 2010
July 2014   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01257139 on ClinicalTrials.gov Archive Site
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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
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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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Non Small-cell Lung Cancer
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.
  • 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
    Intervention: Procedure: Dual-agent therapy or docetaxel alone or best supportive care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
490
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
70 Years and older
No
Contact: Romain Corre, MD romain.corre@chu-rennes.fr
France
 
NCT01257139
EudraCT 2008-008372-13
Not Provided
Direction of Clinical Research, Rennes University Hospital
Rennes University Hospital
Not Provided
Not Provided
Rennes University Hospital
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP