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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00204633 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)
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Scientific title:
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Randomized Phase II-Trial to Determine the Impact of Darbepoetin Alfa on the Frequency of RBC Transfusions in Patients With Metastatic "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP Regimen) |
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Date of first enrolment:
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July 2003 |
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Target sample size:
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108 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00204633 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Joerg T. Hartmann, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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South West German Cancer Center, Medical Center II, University of Tuebingen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Poor prognosis" according IGCCCG-criteria:
- Primary mediastinal tumor
- Gonadal/retroperitoneal germ cell tumor with visceral metastases except of lung
- Poor marker: AFP > 10.000 ng/ml or beta-HCG > 10.000 ng/ml (50.000 IU/l) andd LDH >10
x upper normal limit
- No previous chemotherapy
- Age > 18 years
- Performance-Status: WHO =< 2
- Written informed consent
- Ability to give informed consent
Exclusion Criteria:
- Hemolysis
- Hematological disease with insufficient erythropoiesis
- Patients without sufficient treatment of sideropenia, folate deficiency or vitamin
B12 deficiency
- Uncontrolled arterial hypertension
- Treatment with rh-Erythropoetin during trial
- Creatinin clearance < 50 ml/min
- Insufficient bone marrow function (WBC count < 3.000/ml or platelets < 100.000/µl)
- Other major symptomatic or uncontrolled illnesses not allowing to complete treatment
protocol with the exception of symptoms caused by the primary disease
- Second malignancy, except of completely resected basal cell carcinoma of the skin
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Dysgerminoma
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Intervention(s)
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Drug: Darbepoetin alfa
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Primary Outcome(s)
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frequency of transfusions (reduction from 90% to 65%)
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Secondary Outcome(s)
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developing of hemoglobin levels
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objective remission rate
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progression-free- and overall-survival (pfs, os)
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proportion of patients with no transfusions
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quality of life
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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