What is this study trying to find out about germ cell tumors?

This study evaluates how active surveillance can monitor low-risk germ cell tumors and compares chemotherapy treatments using carboplatin versus cisplatin for standard risk patients. It aims to understand survival rates, treatment side effects, and patient quality of life. The research is sponsored by the Children's Oncology Group to improve care for pediatric and young adult patients.

Who may be eligible for this germ cell tumor clinical trial?

Patients of any age with low-risk stage I germ cell tumors or patients under 25 years old with standard risk malignant germ cell tumors may be eligible. Both males and females can participate. Eligibility requires newly diagnosed tumors and the ability to receive chemotherapy if assigned. Please review eligibility criteria for more details.

Is there any cost to participate in this germ cell tumor clinical trial?

Study-related care, including chemotherapy drugs and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 3

All Genders

ID03067181

A Phase 3 Study of Active Surveillance and Chemotherapy Comparing Carboplatin vs. Cisplatin for Pediatric and Adult Patients With Germ Cell Tumors

Led by Children's Oncology Group · Updated on 2026-05-05

1780

Participants Needed

629

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating how well active surveillance helps doctors monitor patients with low-risk germ cell tumors after surgical removal. The study also compares chemotherapy treatments using carboplatin versus cisplatin in pediatric, adolescent, and young adult patients with metastatic standard risk germ cell tumors. It aims to determine overall survival, event-free survival, and side effects such as hearing loss among these patients. The study includes patients with low-risk stage I ovarian immature teratoma or stage I non-seminoma or seminoma germ cell tumors who undergo observation. Patients with standard risk tumors are randomly assigned to receive one of four chemotherapy regimens combining bleomycin, etoposide, carboplatin, or cisplatin, given intravenously on specific days over cycles repeating every 21 days. Treatments continue for up to 3 or 4 cycles if no disease progression or unacceptable side effects occur. Throughout treatment and observation, patients undergo imaging scans, blood sample collection, tumor biopsies if needed, and pulmonary function tests. Participants will be followed with regular imaging and blood tests to monitor tumor response and recurrence, including CT, MRI, and chest x-rays. Follow-up visits occur every 2 months for the first year, then every 3 to 6 months through year 2, every 6 months for years 3 to 5, and annually up to 10 years. The study also assesses hearing outcomes, body composition, tumor marker decline, neuropathy, and serum microRNA over time to better understand treatment effects and patient quality of life.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

You may qualify if you...

No age limit for low risk patients with stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant germ cell tumors
Patients under 11 years old for standard risk 1 group
Patients aged 11 to under 25 years for standard risk 2 group
Newly diagnosed with stage I germ cell tumor for low risk arms or stage II or higher malignant germ cell tumor for standard risk arms
Histologic confirmation of primary extracranial germ cell tumor is required in most cases
Low risk ovarian immature teratoma with specified tumor marker limits
Low risk stage I non-seminoma germ cell tumors with specific histology
Low risk stage I seminoma germ cell tumors with specific histology
Standard risk groups with specific sites, stages, histology, and tumor marker criteria
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
Adequate organ function for chemotherapy patients
Medically fit to receive protocol treatment without contraindications
Ability to fluently speak and read English for certain patient-reported outcome sub-study
Prior chemotherapy allowed for specific sub-study patients
Followed for cancer care at designated institutions

You will not qualify if you...

Diagnoses not listed including stage I testicular cancer post-primary RPLND, pure ovarian or extragonadal dysgerminoma/seminoma, pure mature teratoma, pure immature teratoma with AFP ≥ 1000 ng/mL
Poor risk germ cell tumors as defined by stage and risk criteria
Primary central nervous system germ cell tumors
Germ cell tumors with somatic malignant transformation
Spermatocytic seminoma
Prior systemic therapy for current cancer diagnosis
Prior radiation therapy except specific CNS irradiation for brain metastases in certain patients
Significant pre-existing respiratory disease contraindicating bleomycin use
Pregnant or lactating females for chemotherapy patients
Sexually active patients of reproductive potential not using effective contraception during study participation

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