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

This study is currently recruiting participants.

Verified by Rigshospitalet, Denmark, May 2008

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00273494

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 III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Liothyronine sodium Triiodothyronine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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).

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

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

Keywords provided by Rigshospitalet, Denmark:

N2 disease
Non-small cell lung cancer
Surgery
Neoadjuvant chemotherapy

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009