Scandinavian Neoadjuvant Phase III Study of Induction Chemotherapy Followed by Irradiation Alone or Surgery Plus Irradiation in NSCLC Stage IIIA/N2 (T1N2, T2N2, T3/N2).
Phase 3
18 Years
75 Years
18 Years
75 Years
Open (Enrolling)
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
Scandinavian Neoadjuvant Phase III Study of Induction Chemotherapy Followed by Irradiation Alone or Surgery Plus Irradiation in NSCLC Stage IIIA/N2 (T1N2, T2N2, T3/N2).
Patients are after staging randomised to neoadj. chemotherapy followed by surgery followed
by irradiation or to chemotherapy followed by irradiation.
Endpoint is survival.
Inclusion Criteria:
- Histologically verified NSCLC
- Stage IIIA/N2
- age 18-75
- Lung function test allowing surgery
- Mediastinoscopy performed
Exclusion Criteria:
- Prior chemotherapy
- Prior irradiation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Survival
Principal Investigator
Jens B. Sorensen, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Rigshospitalet, Denmark
Authority:
Denmark: National Board of Health
Study ID:
Surgery in NSCLC stage IIIA/N2
NCT ID:
NCT00273494
Start Date:
January 1998
Completion Date:
January 2008
Related Keywords:
- Non-Small Cell Lung Cancer
- N2 disease
- Non-small cell lung cancer
- Surgery
- Neoadjuvant chemotherapy
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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