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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Glioblastoma; WHO Grade III Glioma; WHO Grade II Glioma
• Intervention / Treatment: Radiation: Intensity-Modulated Radiation Therapy; Other: Quality-of-Life

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 18 months

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Investigators: Principal Investigator: Wenyin Shi, MD, Thomas Jefferson University

Publications and helpful links

General Publications

• Niazi M, Russial O, Cappelli L, Miller R, Chen Y, Vakhnenko Y, Liu H, Shi W. Efficacy of scalp-sparing volumetric-modulated arc therapy approach in reducing scalp radiation dose for patients with glioblastoma: a cross-sectional study. Chin Clin Oncol. 2023 Aug;12(4):36. doi: 10.21037/cco-23-15.

Helpful Links

• Thomas Jefferson University Hospital
• Sidney Kimmel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Therapeutics; Public Health; Environment and Public Health; Health Status; Demography; Epidemiologic Measurements; Radiotherapy; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Quality of Life; Radiotherapy, Intensity-Modulated
• Other Study ID Numbers: 17D.074; JT 9581 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes