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NCT00053352 · ClinicalTrials.gov registry record · Phase 3
Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors
A Phase 3 study of Childhood Teratoma and Childhood Extracranial Germ Cell Tumor, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 302
- Enrollment target
- 20
- Study locations
NCT00053352 is a Phase 3 study of Childhood Teratoma and Childhood Extracranial Germ Cell Tumor that has completed, run by Children's Oncology Group. The registered enrollment target is 302 participants. The trial reports 20 study locations across 8 states.
The verdict
NCT00053352, a Phase 3 study of Childhood Teratoma and Childhood Extracranial Germ Cell Tumor, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 302 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG cisplatin
- DRUG etoposide
- PROCEDURE conventional surgery
- BIOLOGICAL bleomycin sulfate
Study Locations (20)
California
- Southern California Permanente Medical Group - Downey
- Loma Linda University Medical Center - Loma Linda
- Miller Children's Hospital - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Children's Hospital Central California - Madera
- Children's Hospital and Research Center at Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Childrens Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Sutter General Hospital - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- University of California San Francisco Medical Center-Parnassus - San Francisco
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale University - New Haven
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Phoenix Childrens Hospital - Phoenix
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Alfred I duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2003-11-03 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00053352
The ClinicalTrials.gov registry entry for NCT00053352 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Childhood Teratoma appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT00053352 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Connecticut, Alabama.
Frequently Asked Questions
What is clinical trial NCT00053352 about?
NCT00053352 is a clinical study titled "Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors". 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 m...
What is the current status of trial NCT00053352?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 302 participants. The study started on 2003-11-03. Estimated completion is 2021-06-30.
What conditions does trial NCT00053352 study?
This clinical trial studies the following conditions: Childhood Teratoma, Childhood Extracranial Germ Cell Tumor, Childhood Extragonadal Germ Cell Tumor, Childhood Malignant Ovarian Germ Cell Tumor, Childhood Malignant Testicular Germ Cell Tumor.
What interventions are being tested in trial NCT00053352?
The interventions under investigation include: laboratory biomarker analysis (OTHER), cisplatin (DRUG), etoposide (DRUG), conventional surgery (PROCEDURE), bleomycin sulfate (BIOLOGICAL).
Who is sponsoring clinical trial NCT00053352?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00053352 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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