CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 302 enrolled
Drug / intervention
cisplatin +4 moredrug
Likely dose
Cisplatin, etoposide, and bleomycin sulfate IV (specific doses not provided in trial record)AI-extracted
Key inclusion· 5
  • ✓Extracranial germ cell tumor with malignant histology (yolk sac tumor, embryonal carcinoma, or choriocarcinoma); mixed GCTs eligible if one of these histologies is present
  • ✓Low-risk disease: Stage I gonadal tumors (testicular/ovarian) with complete surgical and radiologic staging, OR intermediate-risk disease: Stage II-IV testicular, Stage II-III ovarian, or Stage I-II extragonadal malignant GCT, OR relapsed stage I gonadal or teratoma patients with malignant component
  • ✓Alpha-fetoprotein and beta human chorionic gonadotropin tumor markers known before enrollment or therapy initiation (repeat if >5 days from original draw)
  • ✓Enrolled within 6 weeks of original diagnostic surgery
Key exclusion· 4
  • ✕Stage IV ovarian or Stage III-IV extragonadal GCT
  • ✕Intracranial GCT
  • ✕Pure mature or immature teratoma, pure dysgerminoma, or seminoma
  • ✕Non-germ cell components in tumor (e.g., primitive neuroectodermal tumors, rhabdomyosarcoma)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00053352
NCT00053352Phase 3Completed
CompareCT.gov

A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors

Children's Oncology Group·interventional·Posted Jan 28, 2003·Updated Jul 13, 2021

In Brief

A Phase 3 clinical trial evaluating conventional surgery, cisplatin, and 3 other interventions for Childhood Embryonal Tumor and 17 related conditions. Completed, enrolled 302 participants across 126 sites in 6 countries.

Detailed Summary

This phase III trial is studying surgery followed by combination chemotherapy to see how well it works in treating children with germ cell tumors that are not located in the head. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is effective in decreasing the recurrence of childhood germ cell tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChildhood Embryonal Tumor, Childhood Extracranial Germ Cell Tumor, Childhood Extragonadal Germ Cell Tumor, Childhood Malignant Ovarian Germ Cell Tumor, Childhood Malignant Testicular Germ Cell Tumor, Childhood Teratoma, Ovarian Embryonal Carcinoma, Ovarian Yolk Sac Tumor, Stage II Malignant Testicular Germ Cell Tumor, Stage IIA Ovarian Germ Cell Tumor, Stage IIB Ovarian Germ Cell Tumor, Stage IIC Ovarian Germ Cell Tumor, Stage III Malignant Testicular Germ Cell Tumor, Stage IIIA Ovarian Germ Cell Tumor, Stage IIIB Ovarian Germ Cell Tumor, Stage IIIC Ovarian Germ Cell Tumor, Testicular Choriocarcinoma and Yolk Sac Tumor, Testicular Embryonal Carcinoma
CountriesAustralia, Canada, New Zealand, Puerto Rico, Switzerland, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 28, 2003
Enrollment StartNov 3, 2003
Primary CompletionOct 1, 2013
Study CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 9.9 yearsPosted 23.4 years ago

Interventions

conventional surgeryprocedure

cisplatindrug

Given IV

etoposidedrug

Given IV

bleomycin sulfatebiological

Given IV

laboratory biomarker analysisother

Correlative studies