Preference Study With Elderly Patients Recurrent Ovarian Cancer

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00170690

Enrollment

123

Registered

2005-09-15

Start date

2004-08-31

Completion date

2012-04-30

Last updated

2013-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Brief 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.

Interventions

DRUGTreosulfan

Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

70 Years to No maximum

Healthy volunteers

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/ ml. * 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 range * simultaneous radiotherapy

Design outcomes

Primary

Measure	Time frame
Comparison of patient´s compliance in both arms defined as therapy break-offs	during study treatment

Secondary

Measure	Time frame
Toxicity, overall survival, progression-free survival	during study treatment and follow-up

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026