We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00273507
First Posted: January 9, 2006
Last Update Posted: September 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  Purpose
Randomised trial of chemotherapy or not before surgery in early resectable stages of NSCLC (IB, IIA, IIB, and IIIA/N2).

Condition Intervention Phase
Non-small Cell Lung Cancer Drug: Carboplatin and Paclitaxel Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy in Resectable NSCLC Stages IB, IIA, IIB, and IIIA/T3 But Not IIIA/N2

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Survival

Secondary Outcome Measures:
  • Time to progression
  • Complete resection rate

Estimated Enrollment: 270
Study Start Date: January 1998
Estimated Study Completion Date: January 2006
Detailed Description:
Randomisation between 3 courses of neoadjuvant Carboplatin plus Paclitaxel or no chemotherapy before surgery.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT00273507


Locations
Denmark
Dept. Oncology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Chair: Jens B. Sorensen, MD Dept. Oncology, Rigshospitalet
  More Information

ClinicalTrials.gov Identifier: NCT00273507     History of Changes
Other Study ID Numbers: Neoadjuvant treatment in NSCLC
First Submitted: January 5, 2006
First Posted: January 9, 2006
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by Rigshospitalet, Denmark:
Non-small cell lung cancer
neoadjuvant
resection

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
Carboplatin
Antineoplastic Agents