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

This study has been terminated.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00273507
First received: January 5, 2006
Last updated: September 17, 2009
Last verified: September 2009
History of Changes
  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
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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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
neoadjuvant
resection

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013