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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00273494
First received: January 5, 2006
Last updated: May 21, 2008
Last verified: May 2008

January 5, 2006
May 21, 2008
January 1998
Not Provided
Survival
Same as current
Complete list of historical versions of study NCT00273494 on ClinicalTrials.gov Archive Site
time to progression
Same as current
Not Provided
Not Provided
 
Neoadjuvant Chemotherapy Plus/Minus Surgery in Non-Small-Cell Lung Cancer (NSCLC) Stage IIIA/N2
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).

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

Patients are randomised to surgery or not.

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

Endpoint is survival.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
Procedure: Surgery
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
406
January 2008
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior chemotherapy
  • Prior irradiation
Both
18 Years to 75 Years
No
Contact: Jens B. Sorensen, MD 35454372 jbsonk@rh.dk
Denmark
 
NCT00273494
Surgery in NSCLC stage IIIA/N2
Not Provided
Not Provided
Rigshospitalet, Denmark
Not Provided
Study Chair: Jens B. Sorensen, MD Rigshospitalet, Denmark
Rigshospitalet, Denmark
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP