Neoadjuvant Chemotherapy Plus/Minus Surgery in Non-Small-Cell Lung Cancer (NSCLC) Stage IIIA/N2

Phase 3

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT00273494
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Study Timeline

• Study Start: 1998-01
• Study First Submitted: 2006-01-05
• Study First Submitted QC: 2006-01-05
• Study First Posted: 2006-01-09
• Study Completion: 2008-01
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-21
• Last Update Posted: 2008-05-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

• Histologically verified NSCLC
• Stage IIIA/N2
• age 18-75
• Lung function test allowing surgery
• Mediastinoscopy performed

Exclusion Criteria

• Prior chemotherapy
• Prior irradiation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Survival

Secondary Outcome Measures

Name	Time	Method
time to progression

Trial Locations

Locations (1)

Dept. Oncology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark