Health Trials

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

ConditionsChildhood Extracranial Germ Cell TumorExtragonadal Embryonal CarcinomaGerm Cell TumorMalignant Germ Cell TumorMalignant Ovarian TeratomaStage I Ovarian ChoriocarcinomaStage I Ovarian Embryonal Carcinoma AJCC v6 and v7Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7Stage I Testicular Choriocarcinoma AJCC v6 and v7Stage I Testicular Embryonal Carcinoma AJCC v6 and v7Stage I Testicular Seminoma AJCC v6 and v7Stage I Testicular Yolk Sac Tumor AJCC v6 and v7Stage II Ovarian ChoriocarcinomaStage II Ovarian Embryonal Carcinoma AJCC v6 and v7Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7Stage II Testicular Choriocarcinoma AJCC v6 and v7Stage II Testicular Embryonal Carcinoma AJCC v6 and v7Stage II Testicular Yolk Sac Tumor AJCC v6 and v7Stage III Ovarian ChoriocarcinomaStage III Ovarian Embryonal Carcinoma AJCC v6 and v7Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7Stage III Testicular Choriocarcinoma AJCC v6 and v7Stage III Testicular Embryonal Carcinoma AJCC v6 and v7Stage III Testicular Yolk Sac Tumor AJCC v6 and v7Stage IV Ovarian ChoriocarcinomaStage IV Ovarian Embryonal Carcinoma AJCC v6 and v7Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7Testicular Mixed Choriocarcinoma and Embryonal CarcinomaTesticular Mixed Choriocarcinoma and TeratomaTesticular Mixed Choriocarcinoma and Yolk Sac Tumor
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChildren's Oncology Group

About this trial

This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.

Eligibility criteria

Qualifiers

There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites])

Standard risk 1: Patients must be < 11 years of age at enrollment

Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment

Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with malignant germ cell tumor (stage II or higher).

Disqualifiers

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

Pure ovarian or extragonadal dysgerminoma/seminoma

Pure mature teratoma

Pure immature teratoma with alpha-fetoprotein (AFP) >= 1000 ng/mL

Trial design

Treatments tested in this trial

  • Best Practice
  • Biopsy Procedure
  • Biospecimen Collection
  • Bleomycin Sulfate
  • Carboplatin
  • Cisplatin
  • Computed Tomography
  • Etoposide
  • Magnetic Resonance Imaging
  • Pulmonary Function Test
  • Questionnaire Administration

Treatment groups

1,780 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Children's Oncology Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov