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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03251027
• Other study ID #: 17D.074
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Thomas Jefferson University
• Contact: Wenyin Shi, MD
• Phone: (215) 955-6702
• Email: wenyin.shi[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioma
• WHO Grade II Glioma
• WHO Grade III Glioma

Intervention

Radiation:
• Intensity-Modulated Radiation Therapy
Undergo IM-SRT

Other:
• Quality-of-Life
Ancillary studies

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital