NCT00273494

Brief Summary

Hypothesis is that surgery is of benefit in locally advanced NSCLC with N2 disease. Patients are randomised to surgery or not.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
406

participants targeted

Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jan 1998

Longer than P75 for phase_3 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

May 22, 2008

Status Verified

May 1, 2008

First QC Date

January 5, 2006

Last Update Submit

May 21, 2008

Conditions

Non-Small Cell Lung Cancer

Keywords

N2 diseaseNon-small cell lung cancerSurgeryNeoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Survival

Secondary Outcomes (1)

  • time to progression

Interventions

SurgeryPROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Prior chemotherapy
  • Prior irradiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Oncology, Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jens B. Sorensen, MD

    Rigshospitalet, Denmark

    STUDY CHAIR

Central Study Contacts

Jens B. Sorensen, MD

CONTACT

35454372jbsonk@rh.dk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2006

First Posted

January 9, 2006

Study Start

January 1, 1998

Study Completion

January 1, 2008

Last Updated

May 22, 2008

Record last verified: 2008-05

Locations

DK(1)