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

May 21, 2008 updated by: Rigshospitalet, Denmark

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).

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

Patients are randomised to surgery or not.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

406

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jens B. Sorensen, MD
  • Phone Number: 35454372
  • Email: jbsonk@rh.dk

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Dept. Oncology, Rigshospitalet
        • Contact:
          • Jens B. Sorensen, MD
          • Phone Number: 35454372
          • Email: jbsonk@rh.dk
        • Contact:
          • Jens B. Sorensen, MD
          • Phone Number: jbsonk@rh.dk 35454372
        • Principal Investigator:
          • Jens B. Sorensen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically verified NSCLC
  • Stage IIIA/N2
  • age 18-75
  • Lung function test allowing surgery
  • Mediastinoscopy performed

Exclusion Criteria:

  • Prior chemotherapy
  • Prior irradiation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival

Secondary Outcome Measures

Outcome Measure
time to progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Chair: Jens B. Sorensen, MD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Study Completion

January 1, 2008

Study Registration Dates

First Submitted

January 5, 2006

First Submitted That Met QC Criteria

January 5, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Estimate)

May 22, 2008

Last Update Submitted That Met QC Criteria

May 21, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Surgery in NSCLC stage IIIA/N2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Small Cell Lung Cancer

Clinical Trials on Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe