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Preference Study With Elderly Patients Recurrent Ovarian Cancer

Sponsor
North Eastern German Society of Gynaecological Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00170690
Collaborator
(none)
123
Enrollment
1
Location
2
Arms
92
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
123 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Präferenz-Studie Bei älteren Patientinnen Mit Ovarialkarzinomrezidiv: Treosulfan Oral vs. intravenös
Study Start Date :
Aug 1, 2004
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc

Drug: Treosulfan
Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc
Experimental: 2

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

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

Outcome Measures

Primary Outcome Measures

  1. Comparison of patient´s compliance in both arms defined as therapy break-offs [during study treatment]

Secondary Outcome Measures

  1. Toxicity, overall survival, progression-free survival [during study treatment and follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charité Campus Virchow-Klinikum Berlin Germany 13533

Sponsors and Collaborators

  • North Eastern German Society of Gynaecological Oncology

Investigators

  • Principal Investigator: Jalid Sehouli, Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00170690
Other Study ID Numbers:
  • 3401000
First Posted:
Sep 15, 2005
Last Update Posted:
Jun 3, 2013
Last Verified:
May 1, 2013
Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Treosulfan
Busulfan

Study Results

No Results Posted as of Jun 3, 2013