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:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT00453232
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Patients must fulfill all of the following criteria for 1 of the following diagnoses:
* Nonseminoma germ cell tumor (intermediate risk)
* Testis or retroperitoneal primary
* Abnormal markers (alpha fetoprotein \[AFP\] \> 1,000 and \< 10,000 ng/mL, human chorionic gonadotropin \[HCG\] \> 5,000 and \< 50,000 IU/L, lactate dehydrogenase \[LDH\] \> 1.5 times and \< 10 times upper limit of normal \[ULN\])
* No liver, bone, brain, or other nonpulmonary visceral metastasis
* Histologic confirmation is not required if AFP or HCG are grossly elevated
* Nonseminoma germ cell tumor (poor prognosis) meeting 1 of the following criteria:
* Mediastinal primary
* Nonpulmonary visceral metastases
* Poor markers (AFP \> 10,000 ng/mL, HCG \> 50,000 IU/L, LDH \> 10 times ULN)
* Histologic confirmation not required if AFP or HCG are grossly elevated
* Seminoma (intermediate prognosis)
* Histological confirmation is required
* Any primary site
* Nonpulmonary visceral metastases must be present
* Normal AFP
* Any HCG
* Any LDH
* Surveillance relapse
* Must fulfill appropriate criteria above according to initial histology
PATIENT CHARACTERISTICS:
* Neutrophil count ≥ 1,000/mm³
* Platelet count ≥ 100,000/mm³
* Must have adequate renal function (creatinine clearance ≥ 60 mL/min)
* No prior malignancy except basal cell carcinoma
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy or radiotherapy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00453232
Study Brief:
Protocol Section:
NCT00453232