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Childhood Extracranial Germ Cell TumorChildren's healthProcedureBiologicalDrugPhase 3

What this study is

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.

What's being tested

  • Best Practice

    Intervention · OTHER

    Undergo observation

  • Biopsy Procedure

    Intervention · PROCEDURE

    Undergo a tumor biopsy

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo blood sample collection

  • Bleomycin Sulfate

    Intervention · BIOLOGICAL

  • Carboplatin

    Intervention · DRUG

  • Cisplatin

    Intervention · DRUG

  • Computed Tomography

    Intervention · PROCEDURE

    Undergo a CT scan

  • Etoposide

    Intervention · DRUG

  • Magnetic Resonance Imaging

    Intervention · PROCEDURE

    Undergo MRI

  • Pulmonary Function Test

    Intervention · PROCEDURE

    Undergo a pulmonary function test

  • Questionnaire Administration

    Intervention · OTHER

    Ancillary studies

All of Bleomycin Sulfate, Carboplatin, Cisplatin, Etoposide

Given IV

Study details

Official 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
Sponsor
Children's Oncology Group
Conditions
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 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
Enrolling
1,780 people
Starts
2017-05-25
Est. completion
2027-06-30
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗