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Sponsored by: |
North Eastern Germany Society of Gynaecologic Oncology |
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Information provided by: | North Eastern Germany Society of Gynaecologic Oncology |
ClinicalTrials.gov Identifier: | NCT00170690 |
Comparison of the patient compliance treosulfan oral vs. intravenous (defined as end of therapy for the patient)
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: Treosulfan |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 160 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | June 2013 |
Approx. 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 Dtage 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.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Werner Lichtenegger | 030/ 450 564 052 | studiensekretariat.agovarialca@charite.de |
Germany | |
Charité Campus Virchow-Klinikum | Recruiting |
Berlin, Germany, 13533 | |
Contact: Werner Lichtenegger 030/ 450 640 52 studiensekretariat.agovarialca@charite.de | |
Principal Investigator: Werner Lichtenegger |
Principal Investigator: | Jalid Sehouli | Charité Campus Virchow Klinikum |
Study ID Numbers: | 3401000 |
Study First Received: | September 12, 2005 |
Last Updated: | February 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00170690 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Genital Diseases, Female Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases |
Urogenital Neoplasms Endocrinopathy Ovarian Diseases Treosulfan Recurrence Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions Adnexal Diseases |