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

Phase 3
70 Years
Not Enrolling
Ovarian Cancer

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Trial Information

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

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.

Inclusion Criteria:

- patient with relapsed ovarian cancer

- study therapy of third regime

- measurable or evaluable tumor lesions or progression defined as CA-125 more than >=
100 U/ ml.

- Age >= 70 years

- ECOG 0-2

- written informed consent

Exclusion Criteria:

- Pretreatment with treosulfan

- patient without measurable or evaluable tumor lesions or CA-125 more than >= 100 U/

- no adequate bone marrow function (leukocyte <= 2,9 x 109/l, platelets <= 100 x 109/ l

- creatinin and bilirubin within >= 1,25 x fold of the reference laboratory´s normal

- simultaneous radiotherapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of patient´s compliance in both arms defined as therapy break-offs

Outcome Time Frame:

during study treatment

Safety Issue:


Principal Investigator

Jalid Sehouli

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charité Campus Virchow Klinikum


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

August 2004

Completion Date:

April 2012

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms