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

Summary

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.

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

Interventions

OTHER

Best Practice

Undergo observation

PROCEDURE

Biopsy Procedure

Undergo a tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

BIOLOGICAL

Bleomycin Sulfate

Given IV

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo a CT scan

DRUG

Etoposide

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Pulmonary Function Test

Undergo a pulmonary function test

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• A. L Frazier · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-25

Primary Completion

2027-06-30

Completion

2027-06-30

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• India
• Japan
• New Zealand
• Puerto Rico
• Saudi Arabia
• United Kingdom

Study Locations