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

This study has been terminated.

First Received on January 5, 2006. Last Updated on September 17, 2009 History of Changes

Sponsor:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00273507

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 III

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

Drug Information available for: Paclitaxel Carboplatin

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 February 09, 2012