NCT00168883

Brief Summary

This is a randomized study to assess the efficacy and safety of chemotherapy with platin compared to chemotherapy without platin.

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
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2002

Typical duration for phase_2

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

October 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

November 1, 2006

Status Verified

September 1, 2006

First QC Date

September 9, 2005

Last Update Submit

October 31, 2006

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

NSCLCcurative non-treatable NSCLC UICC stage IIIB and IV

Outcome Measures

Primary Outcomes (2)

  • Determination of response rate (stable disease [SD] or better)

  • Determination of safety of the combination and life quality

Secondary Outcomes (3)

  • Determination of remission rate

  • Determination of time to progression

  • Determination of 1-year survival rate

Interventions

CarboplatinDRUG
PaclitaxelDRUG
VinorelbineDRUG

Eligibility Criteria

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

You may qualify if:

  • Chemotherapy naive patients with histologically confirmed NSCLC stage III and IV

You may not qualify if:

  • New York Heart Association (NYHA) III or IV
  • Brain metastases
  • Neurotoxicity Grade 2 or greater

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematology & Oncology Charité CBF Berlin

Berlin, State of Berlin, 12203, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CarboplatinPaclitaxelVinorelbine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Ulrich Keilholz, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrich Keilholz, MD

CONTACT

+49-30-8445-3596ulrich.keilholz@charite.de

Alexander Schmittel, MD

CONTACT

+49-30-8445-3090alexander.schmittel@charite.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

October 1, 2002

Study Completion

December 1, 2006

Last Updated

November 1, 2006

Record last verified: 2006-09

Locations

DE(1)