Charité Campus Virchow-Klinikum
Berlin, 13533, Germany
NCT Number: NCT00170690
Comparison of the patient compliance treosulfan oral vs. intravenous (defined as end of therapy for the patient)
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Notify Me70 year and older
Female
Interventional
Phase 3
Berlin, 13533, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc
Time frame: during study treatment
Time frame: during study treatment and follow-up
North Eastern German Society of Gynaecological Oncology
Other
Präferenz-Studie Bei älteren Patientinnen Mit Ovarialkarzinomrezidiv: Treosulfan Oral vs. intravenös
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