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Preference Study With Elderly Patients Recurrent Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Treosulfan
Treosulfan
Sponsored by
North Eastern German Society of Gynaecological Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Charité Campus Virchow-Klinikum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Toxicity, overall survival, progression-free survival

Full Information

First Posted
September 12, 2005
Last Updated
May 31, 2013
Sponsor
North Eastern German Society of Gynaecological Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00170690
Brief Title
Preference Study With Elderly Patients Recurrent Ovarian Cancer
Official Title
Präferenz-Studie Bei älteren Patientinnen Mit Ovarialkarzinomrezidiv: Treosulfan Oral vs. intravenös
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
North Eastern German Society of Gynaecological Oncology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparison of the patient compliance treosulfan oral vs. intravenous (defined as end of therapy for the patient)
Detailed Description
Approximately 60% of all cancer diseases appear to people aged 65 years and older. Ovarian cancer is the most frequent cause of death among gynaecological malignant tumours. Since the highest carcinoma incidence is between the 60th and 70th year more women will come down with ovarian cancer because of increased life expectancy. At least 65% of patients with FIGO stage III/IV will exhibit a relapse or progress after first-line therapy. In most studies the age of the patients is limited to 65 years. It could be shown that especially elder patients often receive an inadequate operative and cytostatic therapy resulting in a worse prognosis. Patients aged 70 years or elder who will be treated with treosulfan, given oral or intravenous, shall be compared regarding the patient compliance, toxicity especially hematological and gastrointestinal toxicity grade 3-4 (CTC NCI), overall survival, progression free survival, quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc
Arm Title
2
Arm Type
Experimental
Arm Description
Treosulfan 600 mg/m² p.o. on day 1-28, 57-84, etc
Intervention Type
Drug
Intervention Name(s)
Treosulfan
Intervention Description
Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc
Intervention Type
Drug
Intervention Name(s)
Treosulfan
Intervention Description
Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc
Primary Outcome Measure Information:
Title
Comparison of patient´s compliance in both arms defined as therapy break-offs
Time Frame
during study treatment
Secondary Outcome Measure Information:
Title
Toxicity, overall survival, progression-free survival
Time Frame
during study treatment and follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jalid Sehouli
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13533
Country
Germany

12. IPD Sharing Statement

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Preference Study With Elderly Patients Recurrent Ovarian Cancer

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