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

Phase 3

Recruiting

• Conditions: Germ Cell Tumor; Germ cell tumor, Teratoma, Embryonal cancer, Choriocarcinoma, York sac tumor, Testicular cancer

• Registration Number: JPRN-jRCTs031180410
• Lead Sponsor: Fujino Akihiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 230

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>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.<br><br>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.<br><br>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 Outcome Measures

Name	Time	Method
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.<br><br>To assess the utility of using an established panel of four circulating microRNAs as a universal marker of diagnosis, recurrence and response to therapy.