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

Rigshospitalet

Status and phase: Unknown; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Procedure: Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00273494

Surgery in NSCLC stage IIIA/N2

Details and patient eligibility

About

Hypothesis is that surgery is of benefit in locally advanced NSCLC with N2 disease.

Patients are randomised to surgery or not.

Full description

Patients are after staging randomised to neoadj. chemotherapy followed by surgery followed by irradiation or to chemotherapy followed by irradiation.

Endpoint is survival.

Enrollment: 406 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Prior chemotherapy
• Prior irradiation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)