NCT00168896

Brief Summary

Comparison of two combination chemotherapies in the treatment of patients with SLCL

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
286

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2001

Longer than P75 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, 2001

Completed
3.9 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

February 14, 2006

Status Verified

September 1, 2001

First QC Date

September 9, 2005

Last Update Submit

February 13, 2006

Conditions

Small Cell Lung Cancer

Keywords

SCLC

Outcome Measures

Primary Outcomes (3)

  • Primary Endpoint:

  • Documentation of the remission rate ( Phase II)

  • Determination of progress free time (Phase III)

Secondary Outcomes (5)

  • Secondary Endpoint:

  • Documentation of progress free time (Phase II)

  • Documentation of objective remission rate ( Phase III)

  • Documentation of 1-year survival rate

  • Documentation of safety of the drug combination

Interventions

Carboplatin plus Irinotecan vs Carboplatin plus EtoposideDRUG

Eligibility Criteria

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

You may qualify if:

  • cytological or histological proven SCLC Stage I or II at 1st diagnosis
  • no prior chemotherapy
  • measurable tumor disease
  • karnofsky performance 70

You may not qualify if:

  • second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)
  • NYHA III
  • chronic diarrhea, obstructive bowel syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematology & Oncology Charité CBF Berlin, Germany

Berlin, State of Berlin, 12203, Germany

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

CarboplatinEtoposide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Ulrich Keilholz, MD

    Charité Campus Benjamin Franklin University Clinic

    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, 2001

Study Completion

December 1, 2006

Last Updated

February 14, 2006

Record last verified: 2001-09

Locations

DE(1)