Trials / Completed
CompletedNCT00238264
Radiation Therapy in Treating Young Patients With Gliomas
A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- Children's Oncology Group · Network
- Sex
- All
- Age
- 3 Years – 20 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Specialized radiation therapy that delivers radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well radiation therapy works in treating young patients with gliomas.
Detailed description
OBJECTIVES: Primary * Determine the marginal-failure rate in young patients with low-grade gliomas treated with reduced-field conformal radiotherapy. Secondary * Determine the progression-free survival, event-free survival, and overall survival rates of young patients treated with this regimen. * Determine quality of life of patients treated with this regimen. * Correlate MIB-1 labeling index with progression-free survival and overall survival of these patients. OUTLINE: This is a multicenter study. Patients undergo reduced-field conformal radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline or 6 weeks after completion of study treatment and then at 2 and 5 years (closed as of 10/27/2010). After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | radiation therapy | Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT |
Timeline
- Start date
- 2006-11-01
- Primary completion
- 2013-12-30
- Completion
- 2018-12-31
- First posted
- 2005-10-13
- Last updated
- 2019-08-07
- Results posted
- 2017-02-23
Locations
145 sites across 6 countries: United States, Australia, Canada, New Zealand, Puerto Rico, Switzerland
Source: ClinicalTrials.gov record NCT00238264. Inclusion in this directory is not an endorsement.