International Clinical Trial of Low and Standard Risk Germ Cell Tumors; AGCT1531

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; AGCT1531

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031180410

Enrollment

230

Registered

2019-03-22

Start date

2020-05-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Germ Cell Tumor Germ cell tumor, Teratoma, Embryonal cancer, Choriocarcinoma, York sac tumor, Testicular cancer

Interventions

No intervention to the Low Risk patients is planned. The standard risk arm will be divided into 2 age-based strata: (1) Standard Risk 1 (SR1) arm, which includes patients up to 11 years of age with CO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Low risk Grade2-3 immature teratoma (Pure immature teratoma or Mixed immature and mature teratoma) 2. Low risk Stage I Malignant Germ Cell Tumor (yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed)) 3. Standard risk Germ Cell Tumor (yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed))

Exclusion criteria

Exclusion criteria: Patients with any diagnosis not listed above. Patients must have had no prior systemic therapy for the current cancer diagnosis. Pregnancy and/or breast feeding.

Design outcomes

Primary

Measure	Time frame
To evaluate whether a strategy of complete surgical resection followed by surveillance can maintain an overall survival rate of at least 95.7% at two years for pediatric, adolescent and adult patients of all ages with Stage I (low risk) malignant germ cell tumors, and at least 98% for patients with ovarian pure immature teratoma. To compare the event-free survival of a carboplatin vs. cisplatin-based regimen in the treatment of pediatric, adolescent and young adult patients with standard risk germ cell tumors. To compare the EFS of a carboplatin-based regimen (CEb) vs. a cisplatin-based regimen (PEb) in children (less than 11 years in age) with standard risk GCT. To compare the EFS of a carboplatin-based regimen (BEC) vs. a cisplatin-based regimen (BEP) in adolescents and young adults (ages 11 - 25 years) with standard risk GCT	—

Measure

Time frame

To evaluate whether a strategy of complete surgical resection followed by surveillance can maintain an overall survival rate of at least 95.7% at two years for pediatric, adolescent and adult patients of all ages with Stage I (low risk) malignant germ cell tumors, and at least 98% for patients with ovarian pure immature teratoma. To compare the event-free survival of a carboplatin vs. cisplatin-based regimen in the treatment of pediatric, adolescent and young adult patients with standard risk germ cell tumors. To compare the EFS of a carboplatin-based regimen (CEb) vs. a cisplatin-based regimen (PEb) in children (less than 11 years in age) with standard risk GCT. To compare the EFS of a carboplatin-based regimen (BEC) vs. a cisplatin-based regimen (BEP) in adolescents and young adults (ages 11 - 25 years) with standard risk GCT

—

Secondary

Measure	Time frame
To compare the incidence of ototoxicity in children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin-based chemotherapy. To assess the utility of using an established panel of four circulating microRNAs as a universal marker of diagnosis, recurrence and response to therapy.	—

Countries

Australia, India, Japan, United Kingdom, United States of America

Contacts

Public ContactMotohiro Kano

Keio University Hospital

knmthr@keio.jp+81-3-5363-3024

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026