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NCT00273494 Clinical Trial

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

Non-Small Cell Lung Cancer Clinical Trial

Official title:
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).

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00273494
Other study ID # Surgery in NSCLC stage IIIA/N2
Secondary ID
Status Recruiting
Phase Phase 3
First received January 5, 2006
Last updated May 21, 2008
Start date January 1998
Est. completion date January 2008

Study information
Verified date May 2008
Source Rigshospitalet, Denmark
Contact Jens B. Sorensen, MD
Phone 35454372
Email jbsonk@rh.dk
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial Summary

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

Patients are randomised to surgery or not.

Description:

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

Endpoint is survival.

Recruitment information / eligibility
Status Recruiting
Enrollment 406
Est. completion date January 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Surgery

Locations
Country Name City State
Denmark Dept. Oncology, Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival
Secondary time to progression
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