Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma

Study Overview
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Brief Summary
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This phase II trial studies how well intensity-modulated stereotactic radiation therapy works in treating patients with grade II-IV glioma. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine the effect of intensity-modulated (IM)-stereotactic radiotherapy (SRT) on the incidence of wound infection (requiring oral/intravenous [IV] antibiotics or surgery), or wound dehiscence. SECONDARY OBJECTIVES: I. To determine the effect of IM-SRT on the incidence of titanium implants as palpable cranial defects due to scalp thinning. II. To determine the effect of IM-SRT on the incidence of hair loss and recovery rate. III. To determine the effect on quality of life (QoL) using European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L). TERTIARY OBJECTIVES: I. To determine if treatment of Intensity-modulated stereotactic radiotherapy (IM-SRT) in patients with newly diagnosed grade II-IV gliomas can decrease the loss of scalp thickness in the coronal plane in T-1W magnetic resonance (MR) images.

Official Title
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Intensity-Modulated Stereotactic Radiotherapy as an Upfront Scalp-Sparing Intervention for the Treatment of Newly Diagnosed Grade II-IV Gliomas

Conditions
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Glioblastoma, WHO Grade II Glioma, WHO Grade III Glioma

Intervention / Treatment
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* Radiation: Intensity-Modulated Radiation Therapy
* Other: Quality-of-Life


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have histologically confirmed low or high grade glioma (grade II-IV) Karnofsky performance status (KPS) >= 60 Patients must have recovered from the effects of surgery; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment Estimated survival >= 3 months Labs considered acceptable per standard of care Patient must sign a study specific informed consent form Radiation treatment must begin >= 3 weeks and =< 8 weeks after surgery Exclusion Criteria: Prior history of scalp radiation or intolerance to standard course of radiation treatment Co-morbidities that would influence wound healing including diabetes (insulin dependent) or smoking (current ongoing use) Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception Karnofsky performance status (KPS) < 60 Patient can't have magnetic resonance imaging (MRI) scan Active collagen vascular disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (IM-SRT)<br>Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks. | Radiation: Intensity-Modulated Radiation Therapy<br>* Undergo IM-SRT<br>Other: Quality-of-Life<br>* Ancillary studies<br>* Other names: Quality-of-Life Assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of wound infection or wound dehiscence | Will assess the impact of intensity-modulated stereotactic radiotherapy (IM-SRT) on the incidence of wound infection, or wound dehiscence. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of titanium implants | Will the impact of IM-SRT on the incidence of titanium implants as palpable cranial defects due to scalp thinning. Rates of titanium implant discomfort will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters. | Up to 2 years | 
| Incidence of hair loss | Will assess the impact of IM-SRT on the incidence of hair loss. Will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters. | Up to 2 years | 
| Incidence of recovery rate | Will assess the impact of IM-SRT on the incidence of recovery rate. Will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters. | Up to 2 years | 
| Quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire | Will assess the impact on quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire. Will be modeled using mixed effects linear regression. Within-cohort changes will be estimated using linear contrasts of model parameters. | Up to 2 years |