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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. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00273494
First Posted: January 9, 2006
Last Update Posted: May 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00273494     History of Changes
Other Study ID Numbers: Surgery in NSCLC stage IIIA/N2
First Submitted: January 5, 2006
First Posted: January 9, 2006
Last Update Posted: May 22, 2008
Last Verified: May 2008

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

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