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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status

Active, not recruiting

Conditions

Glioblastoma

WHO Grade II Glioma

WHO Grade III Glioma

Treatments

Other: Quality-of-Life

Radiation: Intensity-Modulated Radiation Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03251027

17D.074

JT 9581 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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