NCT00312988

Brief Summary

Determination of total survival under Topotecan Monotherapy, Topotecan + Etoposide and Topotecan + Gemcitabine in second-line therapy in patient with recurrent ovarian cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P50-P75 for phase_3 ovarian-cancer

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_3 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
completed

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, 2000

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 11, 2006

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 11, 2006

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

April 10, 2006

Conditions

Ovarian Cancer

Keywords

Ovarian cancer

Outcome Measures

Primary Outcomes (1)

  • overall survival

Secondary Outcomes (3)

  • time to progression

  • determining adverse effects

  • quality of life

Interventions

HycamtinDRUG
GemcitabineDRUG

Eligibility Criteria

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

You may qualify if:

  • Patient with recurrent ovarian cancer
  • Second-line chemotherapy
  • \> = 18 years of age
  • ECOG \< = 2

You may not qualify if:

  • ECOG \> 2
  • Patients with more than one chemotherapy in anamneses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Related Publications (1)

  • Fotopoulou C, Karavas A, Trappe R, Chekerov R, Lichtenegger W, Sehouli J. Venous thromboembolism in recurrent ovarian cancer-patients: A systematic evaluation of the North-Eastern German Society of Gynaecologic Oncology Ovarian Cancer Study Group (NOGGO). Thromb Res. 2009 Nov;124(5):531-5. doi: 10.1016/j.thromres.2009.03.013. Epub 2009 May 8.

    PMID: 19427025DERIVED

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

TopotecanGemcitabine

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Jalid Sehouli

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

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

September 9, 2005

First Posted

April 11, 2006

Study Start

January 1, 2000

Study Completion

December 1, 2009

Last Updated

April 11, 2006

Record last verified: 2005-09

Locations

DE(1)