NCT03251027

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
RADIATION	Intensity-Modulated Radiation Therapy	Undergo IM-SRT
OTHER	Quality-of-Life	Ancillary studies

Timeline

• Start date: 2017-07-17
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2017-08-16
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States