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
  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:


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 April 17, 2014