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

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ClinicalTrials.gov Identifier: NCT00273494
Recruitment Status : Unknown
Verified May 2008 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : January 9, 2006
Last Update Posted : May 22, 2008
Sponsor:
Information provided by:
Rigshospitalet, Denmark

Brief Summary:

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

Patients are randomised to surgery or not.


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Procedure: Surgery Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 406 participants
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).
Study Start Date : January 1998
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. Survival

Secondary Outcome Measures :
  1. time to progression


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

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

ClinicalTrials.gov Identifier: NCT00273494     History of Changes
Other Study ID Numbers: Surgery in NSCLC stage IIIA/N2
First Posted: January 9, 2006    Key Record Dates
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