Back to resultsNeoadjuvant Chemotherapy Plus/Minus Surgery in Non-Small-Cell Lung Cancer (NSCLC) Stage IIIA/N2
Primary Purpose
Non-Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring N2 disease, Non-small cell lung cancer, Surgery, Neoadjuvant chemotherapy
Eligibility 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
Sites / Locations
- Dept. Oncology, RigshospitaletRecruiting
Outcomes
Primary Outcome Measures
Survival
Secondary Outcome Measures
time to progression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00273494
Brief Title
Neoadjuvant Chemotherapy Plus/Minus Surgery in Non-Small-Cell Lung Cancer (NSCLC) Stage IIIA/N2
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 Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
5. Study Description
Brief Summary
Hypothesis is that surgery is of benefit in locally advanced NSCLC with N2 disease.
Patients are randomised to surgery or not.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
N2 disease, Non-small cell lung cancer, Surgery, Neoadjuvant chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
406 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Surgery
Primary Outcome Measure Information:
Title
Survival
Secondary Outcome Measure Information:
Title
time to progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens B. Sorensen, MD
Phone
35454372
Email
jbsonk@rh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens B. Sorensen, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. Oncology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens B. Sorensen, MD
Phone
35454372
Email
jbsonk@rh.dk
First Name & Middle Initial & Last Name & Degree
Jens B. Sorensen, MD
Phone
35454372
Ext
jbsonk@rh.dk
First Name & Middle Initial & Last Name & Degree
Jens B. Sorensen, MD
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Chemotherapy Plus/Minus Surgery in Non-Small-Cell Lung Cancer (NSCLC) Stage IIIA/N2
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