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Neoadjuvant Chemotherapy Plus/Minus Surgery in Non-Small-Cell Lung Cancer (NSCLC) Stage IIIA/N2

NCT ID: NCT00273494

Last Updated: 2008-05-22

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

406 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2008-01-31

Brief Summary

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Hypothesis is that surgery is of benefit in locally advanced NSCLC with N2 disease.

Patients are randomised to surgery or not.

Detailed Description

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Patients are after staging randomised to neoadj. chemotherapy followed by surgery followed by irradiation or to chemotherapy followed by irradiation.

Endpoint is survival.

Conditions

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Non-Small Cell Lung Cancer

Keywords

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N2 disease Non-small cell lung cancer Surgery Neoadjuvant chemotherapy

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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Surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Histologically verified NSCLC
* Stage IIIA/N2
* age 18-75
* Lung function test allowing surgery
* Mediastinoscopy performed

Exclusion Criteria

* Prior chemotherapy
* Prior irradiation
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

Rigshospitalet, Denmark

Locations

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Dept. Oncology, Rigshospitalet

Copenhagen, Copenhagen, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Jens B. Sorensen, MD

Role: CONTACT

Phone: 35454372

Email: [email protected]

Facility Contacts

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Jens B. Sorensen, MD

Role: primary

Jens B. Sorensen, MD

Role: backup

Other Identifiers

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Surgery in NSCLC stage IIIA/N2

Identifier Type: -

Identifier Source: org_study_id