Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT00204633
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00204633
Study Brief:
Protocol Section:
NCT00204633