Status:
COMPLETED
Preference Study With Elderly Patients Recurrent Ovarian Cancer
Lead Sponsor:
North Eastern German Society of Gynaecological Oncology
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
70+ years
Phase:
PHASE3
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 carcinom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00170690
Start Date
August 1 2004
End Date
April 1 2012
Last Update
June 3 2013
Active Locations (1)
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1
Charité Campus Virchow-Klinikum
Berlin, Germany, 13533