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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT00002566
Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of testicular or extragonadal male germ cell tumors Must meet 1 of the following conditions after completion of platinum-based first-line chemotherapy: Complete remission (CR) followed by relapse Partial remission (PR) Prior resection of viable malignancy with elevated tumor markers allowed Initial bulky disease with no CR (significantly reduced but still abnormal in plateau) allowed if there is an increase in biological tumor markers or development of new metastases Seminoma with relapse after CR or PR to cisplatin-based chemotherapy allowed No pure seminoma pre-treated with carboplatin No refractory disease (i.e., documented increase in tumor burden and/or serum tumor marker level during or within 1 month after platinum-containing chemotherapy) CNS involvement allowed
PATIENT CHARACTERISTICS: Age: 16 and over Sex: Male Performance status: WHO 0-2 OR Karnofsky 50-100% Life expectancy: No limits on life expectancy due to severe non-malignant disease Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No severe cardiac disease that would interfere with study therapy Pulmonary: No severe pulmonary disease that would interfere with study therapy Other: HIV negative No severe neurologic or metabolic disease that would interfere with study therapy No psychological, socioeconomic, or geographic circumstances that would preclude study No other concurrent malignancy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy for metastatic disease allowed Surgery: See Disease Characteristics Prior surgery for metastatic disease allowed
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
16 Years
Maximum Age:
120 Years
Study:
NCT00002566
Study Brief:
Protocol Section:
NCT00002566