Status:
COMPLETED
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
Lead Sponsor:
Rennes University Hospital
Conditions:
Non Small-cell Lung Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT01257139
Start Date
January 1 2010
End Date
July 1 2014
Last Update
April 3 2023
Active Locations (45)
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1
CH du Pays d'Aix
Aix-en-Provence, France
2
CHU Amien Picardie
Amiens, France
3
Centre Hospitalier Universitaire d'Angers
Angers, France
4
Centre Hospitalier d'Annecy
Annecy, France