Testicular

Key Eligibility
Newly diagnosed AJCC Stage I, II, III testicular NSGCT
1. Observation Only Arm: AJCC Stage IA, IB, IS, Age less than 50 years old
Monthly tumor marker assessment x 1 year, q2 months for year 2, then q6 months for years 3 and 4.
CXR and abdomen/pelvis CT scan are required at 3 and 12 months.
2. Standard Risk 2 Arm: AJCC Stage II, II, and IGCCC Good Risk, age less than 25 years old.
Patients are randomized between receiving 3 cycles of BEP or BEC
Cycles are 21 days with visits on Day 1-5, 8 and 15. Next cycle begins on Day 22 or when eligibility
criteria are met .

Ovarian Germ Cell Tumors
1. Low risk stratum
No age limit
Newly diagnosed stage I, grade 2 or 3 immature teratoma
2. Standard risk 2 stratum
Age > 11 and < 25
Stage II-IV GCT containing yolk sac tumor and/or embryonal carcinoma and/or choriocarcinoma
3. Visit Summary:
Low risk stratum: Observation with tumor markers q 2 mos first year, q 3 months 2nd year, annually 3rd year, then as clinically
indicated. Imaging at 4 and 12 months in first year, then as clinically indicated.
Standard risk 1 stratum: 4 cycles of chemotherapy q 3 weeks
Standard risk 2 stratum: 3 cycles of chemotherapy q 4 weeks

Key Eligibility
1. Newly diagnosed testicular germ cell tumor less than 45 with IGCCC Intermediate or Poor risk
2. Patients are randomized between standard BEP and accelerated BEP (cisplatin and etoposide given every 2 weeks (days 1-5) x 4 14 day cycles, followed by weekly bleomycin x 4 (21 day cycle )).