An interventional study of Intensity-Modulated Radiation Therapy and Quality-of-Life in Glioblastoma, WHO Grade II Glioma and WHO Grade III Glioma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks.
Radiation: Intensity-Modulated Radiation Therapy · Other: Quality-of-Life
Undergo IM-SRT
Ancillary studies
Also known as: Quality of Life Assessment, Quality-of-Life Assessment
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.
Time frame: Up to 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 2 years
Scalp thickness
Will assess the IM-SRT on scalp thickness as determined by magnetic resonance imaging evaluations of scalp thickness in the coronal plane before conformal radiation therapy (XRT), at 9 months, and 18 months after XRT in the study group compared to time-matched historical controls of patients. Mixed effects linear regression will be used to jointly model scalp thickness measurements at pre-treatment, 9 months, and 18 months. Potential confounding factors (chemotherapy, smoking history, diabetes) will also be included in the model. The residual variance covariance matrix will be assumed to have a compound-symmetric structure to account for the correlation among repeated measurements. Linear contrasts will be used to compare the change from pre-treatment to 9 months between IM-SRT and conformal therapy patients and to compare the change from pre treatment to 18 months between IM-SRT and conformal therapy patients.
Time frame: Up to 18 months
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University