Dysgerminoma
Conditions
Brief summary
The aim is to determine the frequency of RBC transfusion in patients with metastatic poor prognosis germ cell tumor during high-dose chemotherapy (HD-VIP, level 6) with or without Darbepoetin alfa
Interventions
DRUGDarbepoetin alfa
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| frequency of transfusions (reduction from 90% to 65%) | — |
Secondary
| Measure | Time frame |
|---|---|
| proportion of patients with no transfusions | — |
| developing of hemoglobin levels | — |
| objective remission rate | — |
| progression-free- and overall-survival (pfs, os) | — |
| quality of life | — |
Countries
Germany
Outcome results
None listed