Neoadjuvant Chemotherapy Plus/Minus Surgery in Non-Small-Cell Lung Cancer (NSCLC) Stage IIIA/N2
Conditions
Non-Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
N2 disease, Non-small cell lung cancer, Surgery, Neoadjuvant chemotherapy
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Surgery
Type: Procedure
Overall Status
Recruiting
Summary
Hypothesis is that surgery is of benefit in locally advanced NSCLC with N2 disease.

Patients are randomised to surgery or not.
Detailed Description
Patients are after staging randomised to neoadj. chemotherapy followed by surgery followed by irradiation or to chemotherapy followed by irradiation.

Endpoint is survival.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically verified NSCLC

- Stage IIIA/N2

- age 18-75

- Lung function test allowing surgery

- Mediastinoscopy performed

Exclusion Criteria:

- Prior chemotherapy

- Prior irradiation
Location
Dept. Oncology, Rigshospitalet
Copenhagen, Denmark
Status: Recruiting
Contact: Jens B. Sorensen, MD - 35454372 - jbsonk@rh.dk
Start Date
January 1998
Completion Date
January 2008
Sponsors
Rigshospitalet, Denmark
Source
Rigshospitalet, Denmark
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page