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Phase 3
70 Years
Open (Enrolling)
Non Small-cell Lung Cancer

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Trial Information

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

- 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

- 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

- Concurrent participation in another clinical trial.

- Definitive contraindication to steroids or folic acid and vitamin B12 if histology is

- 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

Type of Study:


Study Design:

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

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

Outcome Time Frame:

date of documented progression up to 6 months

Safety Issue:



France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

EudraCT 2008-008372-13



Start Date:

January 2010

Completion Date:

July 2014

Related Keywords:

  • Non Small-cell Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms