NCT00273507

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
270

participants targeted

Target at P25-P50 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
terminated

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

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
4 days 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
Last Updated

September 18, 2009

Status Verified

September 1, 2009

First QC Date

January 5, 2006

Last Update Submit

September 17, 2009

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancerneoadjuvantresection

Outcome Measures

Primary Outcomes (1)

  • Survival

Secondary Outcomes (2)

  • Time to progression

  • Complete resection rate

Interventions

Carboplatin and PaclitaxelDRUG

Eligibility Criteria

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

You may qualify if:

  • NSCLC
  • Stages IB, IIA, IIB, IIIA/T3
  • Lung function test allowing surgery
  • Age 18-75 years

You may not qualify if:

  • Poor lung function
  • Performance status 3-4
  • Mediastinal lymph node involvement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Oncology, Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Jens B. Sorensen, MD

    Dept. Oncology, Rigshospitalet

    STUDY CHAIR

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, 2006

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

DK(1)