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

This study has been terminated.
Information provided by:
Rigshospitalet, Denmark Identifier:
First received: January 5, 2006
Last updated: September 17, 2009
Last verified: September 2009
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00273507

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

No publications provided Identifier: NCT00273507     History of Changes
Other Study ID Numbers: Neoadjuvant treatment in NSCLC 
Study First Received: January 5, 2006
Last Updated: September 17, 2009
Health Authority: Denmark: National Board of Health

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on February 04, 2016