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Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors

Study on treatments for children and adults with germ cell tumors.

Recruiting
All
Phase 3

Germ cell tumors are a type of cancer that can occur in both children and adults, often in reproductive organs like ovaries or testicles. This study looks at how well different treatments work for these tumors. First, doctors remove the tumor, and then they watch closely to see if it comes back. This is called active surveillance. If the tumor is more serious, patients may get chemotherapy, which uses special medicines to kill cancer cells.

Key Points:

  • Length of Study: Patients will be followed for up to 10 years after treatment.
  • Visits Needed: Regular check-ups with scans and blood tests during and after treatment.
  • Risks: Chemotherapy can have side effects like hearing loss or nerve problems.

Patients are put into groups based on their age and type of tumor. They may get one of two chemotherapy plans: one uses a drug called carboplatin, and the other uses cisplatin, both paired with other cancer-fighting drugs. The goal is to see which works better with fewer side effects. Participation is based on age, tumor type, and health conditions. Pregnant or breastfeeding women, and those not willing to use birth control during treatment, cannot join certain parts of the study.

Study details
    Childhood Extracranial Germ Cell Tumor
    Extragonadal Embryonal Carcinoma
    Germ Cell Tumor
    Malignant Germ Cell Tumor
    Malignant Ovarian Teratoma
    Stage I Ovarian Choriocarcinoma
    Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7
    Stage I Ovarian Teratoma AJCC v6 and v7
    Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7
    Stage I Testicular Choriocarcinoma AJCC v6 and v7
    Stage I Testicular Embryonal Carcinoma AJCC v6 and v7
    Stage I Testicular Seminoma AJCC v6 and v7
    Stage I Testicular Yolk Sac Tumor AJCC v6 and v7
    Stage II Ovarian Choriocarcinoma
    Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7
    Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7
    Stage II Testicular Choriocarcinoma AJCC v6 and v7
    Stage II Testicular Embryonal Carcinoma AJCC v6 and v7
    Stage II Testicular Yolk Sac Tumor AJCC v6 and v7
    Stage III Ovarian Choriocarcinoma
    Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7
    Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7
    Stage III Testicular Choriocarcinoma AJCC v6 and v7
    Stage III Testicular Embryonal Carcinoma AJCC v6 and v7
    Stage III Testicular Yolk Sac Tumor AJCC v6 and v7
    Stage IV Ovarian Choriocarcinoma
    Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7
    Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7
    Testicular Mixed Choriocarcinoma and Embryonal Carcinoma
    Testicular Mixed Choriocarcinoma and Teratoma
    Testicular Mixed Choriocarcinoma and Yolk Sac Tumor

NCT03067181

Children's Oncology Group

15 February 2025

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