Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Comparison of the patient compliance treosulfan oral vs. intravenous (defined as end of therapy for the patient)
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc |
|
| 2 | Experimental | Treosulfan 600 mg/m² p.o. on day 1-28, 57-84, etc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treosulfan | Drug | Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of patient´s compliance in both arms defined as therapy break-offs | during study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity, overall survival, progression-free survival | during study treatment and follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jalid Sehouli | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Campus Virchow-Klinikum | Berlin | 13533 | Germany |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C018404 | treosulfan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Treosulfan |
| Drug |
Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc |
|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |