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Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors

NCT00053352 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2021-07-13

Study results available
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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.

Conditions

  • Childhood 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

Interventions

PROCEDURE

conventional surgery

DRUG

cisplatin

Given IV

DRUG

etoposide

Given IV

BIOLOGICAL

bleomycin sulfate

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Anne Frazier, MD · Children's Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-03
Primary Completion
2013-10-01
Completion
2021-06-30

Countries

  • United States
  • Australia
  • Canada
  • New Zealand
  • Puerto Rico
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00053352 on ClinicalTrials.gov