- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00170690
Preference Study With Elderly Patients Recurrent Ovarian Cancer
Präferenz-Studie Bei älteren Patientinnen Mit Ovarialkarzinomrezidiv: Treosulfan Oral vs. intravenös
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Berlin, Germany, 13533
- Charite Campus Virchow-Klinikum
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc
|
Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc
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
|
Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc
Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of patient´s compliance in both arms defined as therapy break-offs
Time Frame: during study treatment
|
during study treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicity, overall survival, progression-free survival
Time Frame: during study treatment and follow-up
|
during study treatment and follow-up
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Busulfan
- Treosulfan
Other Study ID Numbers
- 3401000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
-
Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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University of WashingtonMinnesota Ovarian Cancer AllianceTerminatedStage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage IVA Ovarian Cancer AJCC v8 | Stage IVB Ovarian... and other conditionsUnited States
Clinical Trials on Treosulfan
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Sheba Medical CenterUnknownHodgkin Lymphoma | Non Hodgkin LymphomaIsrael
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IRCCS San RaffaeleUnknownLeukemia | Multiple Myeloma | Hodgkin Lymphoma | Chronic Lymphocytic Leukemia | Chronic Myeloid Leukemia | Myelodysplastic Syndrome | Diffuse Large Cell LymphomaItaly
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Hospices Civils de LyonUnknownHematological Malignancies | Allogeneic TransplantationFrance
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OHSU Knight Cancer InstituteNational Cancer Institute (NCI); medac GmbHCompletedMyelodysplastic Syndromes | LeukemiaUnited States
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IRCCS San RaffaeleTerminatedMultiple Myeloma | Graft Vs Host Disease | Leukemia, Acute | Transplant-Related Hematologic Malignancy | Irradiated Bone MarrowItaly
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Dr. Avichai Shimoni MDCompletedAcute Myeloid Leukemia | Myelodysplastic SyndromeIsrael
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medac GmbHSyneos Health; Celerion; Venn Life SciencesCompletedBone Marrow Failure Syndromes | Inborn Errors of Metabolism | Primary Immunodeficiencies | HaemoglobinopathiesPoland, Czechia, Germany, Italy
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Great Ormond Street Hospital for Children NHS Foundation...Newcastle-upon-Tyne Hospitals NHS TrustCompletedAllogeneic Haematopoietic Stem Cell TransplantationUnited Kingdom
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Center for International Blood and Marrow Transplant...National Marrow Donor Program; Pediatric Blood and Marrow Transplant Consortium and other collaboratorsCompletedAcute Myeloid Leukemia (AML) | Myelodysplastic Syndrome (MDS)United States
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medac GmbHCompleted