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Protocol No. AGCT1531

Principal Investigator DeSantes, Kenneth

Phase III

Age Group Both

Scope National

Sponsor Type National

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

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

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 Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Uterus

    Status Open

    Participating Institutions Gundersen Health System; UW Hospital and Clinics