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

N/AActive Not RecruitingNCT03251027

Sidney Kimmel Cancer Center at Thomas Jefferson University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Glioblastoma WHO Grade II Glioma WHO Grade III Glioma

Interventions

Intensity-Modulated Radiation TherapyRADIATION

Undergo IM-SRT

Quality-of-LifeOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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