Title
A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

Description

Objective
The purpose of this research study is to find out if we can improve the treatment for patients with low risk germ cell tumors, by closely monitoring individuals after their tumor is removed without giving additional surgery with chemotherapy and/or more surgery

Treatment

Key Eligibility
Low Risk Stratum (Stage I Ovarian Immature Teratoma and Stage I Malignant GCT (all sites) Patients must be < 50 years of age at enrollment

Standard Risk 1: Patient must be < 11 years of age at enrollment

Standard Risk 2: Patients must be ≥ 11 and < 25 years of age at enrollment

Newly diagnosed patients must have histologic verification of a primary extracranial germ cell tumor

Elevation of serum tumor markers without histologic confirmation is not sufficient for entry on the trial

Patients must have a performance status corresponding to ECOG scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years
of age

Must have adequate Renal, Liver and Pulmonary Function

Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor

Has experienced prior or ongoing hearing impairment due to chemotherapy or radiotherapy

Exclusion Criteria:

Stage 1 testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)

Pure dysgerminoma and pure seminoma

Pure mature teratoma, COG stage I with AFP > or equal to 1000 mg/mL

Pure immature teratoma COG Stage II - IV or FIGO Stage IC to IV

Poor risk disease (age ≥ 11 years old and COG Stage IV ovarian, COG

Stage III or IV EG, or IGCCC intermediate or poor risk testicular), or Primary CNS germ cell tumor

Can not be pregnant or breast feeding

No prior systemic therapy

Applicable Disease Sites
Anal; Bladder; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Lymphoma; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

Participating Institutions
Gundersen Health System; UW Health University Hospital