Präferenz-Studie Bei älteren Patientinnen Mit Ovarialkarzinomrezidiv: Treosulfan Oral vs. intravenös
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparison of patient´s compliance in both arms defined as therapy break-offs
during study treatment
Yes
Jalid Sehouli
Principal Investigator
Charité Campus Virchow Klinikum
Germany: Federal Institute for Drugs and Medical Devices
3401000
NCT00170690
August 2004
April 2012
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