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Completed

NCT Number: NCT00170690

Preference Study With Elderly Patients Recurrent Ovarian Cancer

Comparison of the patient compliance treosulfan oral vs. intravenous (defined as end of therapy for the patient)

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treosulfan

Drug

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

Primary outcomes

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

    Time frame: during study treatment

Secondary outcomes

  1. Toxicity, overall survival, progression-free survival

    Time frame: during study treatment and follow-up

Sponsors and collaborators

Lead sponsor

North Eastern German Society of Gynaecological Oncology

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2011
Study completion
2012
First posted
Sep 15, 2005
Registry last updated
Jun 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.