Clinical trial NCT03251027: Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma
Official title: Intensity-Modulated Stereotactic Radiotherapy as an Upfront Scalp-Sparing Intervention for the Treatment of Newly Diagnosed Grade II-IV Gliomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioblastoma
WHO Grade II Glioma
WHO Grade III Glioma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of wound infection or wound dehiscence
timeFrame: Up to 2 years
Secondary outcomes:
measure: Incidence of titanium implants
timeFrame: Up to 2 years
measure: Incidence of hair loss
timeFrame: Up to 2 years
measure: Incidence of recovery rate
timeFrame: Up to 2 years
measure: Quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire
timeFrame: Up to 2 years
Other outcomes:
measure: Scalp thickness
timeFrame: Up to 18 months
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Wenyin Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: