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

Monitoring and medication options for germ cell tumor patients.

Recruiting
All
Phase 3

This study looks at how different methods help in treating **germ cell tumors** in children and adults. Germ cell tumors are a type of cancer that can spread from the original organ to other parts of the body, called **metastatic tumors**. The study checks if watching patients closely after surgery, instead of immediate treatment, can work for low-risk tumors. It also compares two chemotherapy drugs: **carboplatin** and **cisplatin**, to see which is better for treating standard-risk tumors.

**Key Points:**

  • Participation may require regular check-ups with imaging and blood tests for up to 10 years.
  • Some patients will receive treatments every 21 days up to 4 cycles, which may include chemotherapy drugs.
  • There may be side effects such as hearing issues, which will be closely monitored.

To join, patients need to meet certain criteria like age limits and specific tumor characteristics. They must also have good organ function if they need chemotherapy. Pregnant or breastfeeding women and those not using contraception during the study cannot participate.

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

30 March 2025

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