NCT00170690

Brief Summary

Comparison of the patient compliance treosulfan oral vs. intravenous (defined as end of therapy for the patient)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at below P25 for phase_3 ovarian-cancer

Timeline
Completed

Started Aug 2004

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

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

7.3 years

First QC Date

September 12, 2005

Last Update Submit

May 31, 2013

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Comparison of patient´s compliance in both arms defined as therapy break-offs

    during study treatment

Secondary Outcomes (1)

  • Toxicity, overall survival, progression-free survival

    during study treatment and follow-up

Study Arms (2)

1

EXPERIMENTAL

Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc

Drug: Treosulfan

2

EXPERIMENTAL

Treosulfan 600 mg/m² p.o. on day 1-28, 57-84, etc

Drug: Treosulfan

Interventions

TreosulfanDRUG

Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc

2

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • patient with relapsed ovarian cancer
  • study therapy of third regime
  • measurable or evaluable tumor lesions or progression defined as CA-125 more than \>= 100 U/ ml.
  • Age \>= 70 years
  • ECOG 0-2
  • written informed consent

You may not qualify if:

  • Pretreatment with treosulfan
  • patient without measurable or evaluable tumor lesions or CA-125 more than \>= 100 U/ ml.
  • no adequate bone marrow function (leukocyte \<= 2,9 x 109/l, platelets \<= 100 x 109/ l
  • creatinin and bilirubin within \>= 1,25 x fold of the reference laboratory´s normal range
  • simultaneous radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Campus Virchow-Klinikum

Berlin, 13533, Germany

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

treosulfan

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

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
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

August 1, 2004

Primary Completion

December 1, 2011

Study Completion

April 1, 2012

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations

DE(1)