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NCT00085735 · ClinicalTrials.gov registry record · Phase 3
Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
A Phase 3 study of Medulloblastoma, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 549
- Enrollment target
- 20
- Study locations
NCT00085735 is a Phase 3 study of Medulloblastoma that has completed, run by Children's Oncology Group. The registered enrollment target is 549 participants, above the 122-participant average among 29 other Medulloblastoma trials with a reported enrollment target (350% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT00085735, a Phase 3 study of Medulloblastoma, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 549 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial is studying how well standard-dose radiation therapy works compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard volume boost radiation therapy works compared to smaller volume boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy is more effective than reduced-dose radiation therapy when given together with chemotherapy after surgery in treating young patients with medulloblastoma.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Cisplatin
- OTHER Laboratory Biomarker Analysis
- RADIATION Craniospinal Irradiation
- RADIATION Involved-Field Radiation Therapy
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Sutter Medical Center Sacramento - Sacramento
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Parnassus - San Francisco
- UCSF Medical Center-Mission Bay - San Francisco
- Santa Barbara Cottage Hospital - Santa Barbara
Alabama
- Children's Hospital of Alabama - Birmingham
- University of Alabama at Birmingham Cancer Center - Birmingham
Arizona
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 549 participants |
| Start Date | 2004-04-30 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00085735
The ClinicalTrials.gov registry entry for NCT00085735 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 549 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 122-participant average among 29 other Medulloblastoma trials with a reported enrollment target (350% higher). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Medulloblastoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00085735 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00085735 about?
NCT00085735 is a clinical study titled "Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma". This randomized phase III trial is studying how well standard-dose radiation therapy works compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard volume boost radiation therapy works compared to smaller volume boost radiation therapy when given together with ch...
What is the current status of trial NCT00085735?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 549 participants. The study started on 2004-04-30. Estimated completion is 2024-12-31.
What conditions does trial NCT00085735 study?
This clinical trial studies the following conditions: Medulloblastoma.
What interventions are being tested in trial NCT00085735?
The interventions under investigation include: Cyclophosphamide (DRUG), Cisplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Craniospinal Irradiation (RADIATION), Involved-Field Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT00085735?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00085735 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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