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

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ClinicalTrials.gov Identifier: NCT00273507
Recruitment Status : Terminated
First Posted : January 9, 2006
Last Update Posted : September 18, 2009
Information provided by:
Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Carboplatin and Paclitaxel Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
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
Study Start Date : January 1998
Estimated Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Carboplatin
U.S. FDA Resources

Primary Outcome Measures :
  1. Survival

Secondary Outcome Measures :
  1. Time to progression
  2. Complete resection rate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

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

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

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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents