Neoadjuvant Chemotherapy in Non Small Cell Lung Cancer (NSCLC) Stages IB, IIA, IIB, and IIIA/T3

September 17, 2009 updated by: Rigshospitalet, Denmark

Neoadjuvant Chemotherapy in Resectable NSCLC Stages IB, IIA, IIB, and IIIA/T3 But Not IIIA/N2

Randomised trial of chemotherapy or not before surgery in early resectable stages of NSCLC (IB, IIA, IIB, and IIIA/N2).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Randomisation between 3 courses of neoadjuvant Carboplatin plus Paclitaxel or no chemotherapy before surgery.

Study Type

Interventional

Enrollment

270

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 Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Dept. Oncology, Rigshospitalet

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:

  • NSCLC
  • Stages IB, IIA, IIB, IIIA/T3
  • Lung function test allowing surgery
  • Age 18-75 years

Exclusion Criteria:

  • Poor lung function
  • Performance status 3-4
  • Mediastinal lymph node involvement

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
Complete resection rate

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, Dept. Oncology, Rigshospitalet

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, 2006

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)

September 18, 2009

Last Update Submitted That Met QC Criteria

September 17, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neoadjuvant treatment in NSCLC

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.

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