Status:
COMPLETED
TAilored Post-Surgical Therapy in Early Stage NSCLC
Lead Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels and EGFR mutations would attain better disease free survival rates than patients in the control arm receivi...
Eligibility Criteria
Inclusion
- NSCLC that is defined as other than predominantly squamous cell histology (squamous cell and/or mixed small cell, non-small cell histology is not permitted)
- Surgically resected NSCLC with pathological stage II or stage IIIA non-N2 (TNM classification 2008)
- Performance status (PS) = 0 or 1
- 18 years \<= age \< 70 years
- Signed inform consent
Exclusion
- Squamous cell carcinoma
- Previous cancer excepted those treated for more than 5 years and considered cured, basocellular skin carcinoma, carcinoma in situ of uterine cervix
- Inadequate renal or cardiac functions
- Pregnant women
- Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, grade ≥ 2 peripheral neuropathy, peptic ulcer disease, erosive esophagitis or gastritis
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2016
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00775385
Start Date
April 1 2009
End Date
January 21 2016
Last Update
March 3 2017
Active Locations (42)
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1
Centre Hospitalier
Aix-en-Provence, France
2
Clinique de L'Europe
Amiens, France
3
Angers - CHU
Angers, France, 49000
4
Centre Hospitalier
Béziers, France