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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
History of Changes
  Purpose

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

Patients are randomised to surgery or not.


Condition Intervention Phase
Non-Small Cell Lung Cancer
 Procedure: Surgery
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Survival

Secondary Outcome Measures:
  • time to progression

Estimated Enrollment: 406
Study Start Date: January 1998
Estimated Study Completion Date: January 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273494

Contacts
Contact: Jens B. Sorensen, MD 35454372 jbsonk@rh.dk

Locations
Denmark
Dept. Oncology, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Jens B. Sorensen, MD     35454372     jbsonk@rh.dk    
Contact: Jens B. Sorensen, MD     35454372 ext jbsonk@rh.dk        
Principal Investigator: Jens B. Sorensen, MD            
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Chair: Jens B. Sorensen, MD Rigshospitalet, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00273494     History of Changes
Other Study ID Numbers: Surgery in NSCLC stage IIIA/N2
Study First Received: January 5, 2006
Last Updated: May 21, 2008
Health Authority: Denmark: National Board of Health

Keywords provided by Rigshospitalet, Denmark:
N2 disease
Non-small cell lung cancer
Surgery
Neoadjuvant chemotherapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013