NCT00170690

Preference Study With Elderly Patients Recurrent Ovarian Cancer

Präferenz-Studie Bei älteren Patientinnen Mit Ovarialkarzinomrezidiv: Treosulfan Oral vs. intravenös

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: North Eastern German Society of Gynaecological Oncology · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Treosulfan	Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc
DRUG	Treosulfan	Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc

Timeline

• Start date: 2004-08-01
• Primary completion: 2011-12-01
• Completion: 2012-04-01
• First posted: 2005-09-15
• Last updated: 2013-06-03

Locations

1 site across 1 country: Germany