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

NCT ID: NCT00273507

Last Updated: 2009-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2006-01-31

Brief Summary

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

Detailed Description

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

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Carboplatin and Paclitaxel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Principal Investigators

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Jens B. Sorensen, MD

Role: STUDY_CHAIR

Dept. Oncology, Rigshospitalet

Locations

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Dept. Oncology, Rigshospitalet

Copenhagen, Copenhagen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Neoadjuvant treatment in NSCLC

Identifier Type: -

Identifier Source: org_study_id

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