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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03251027
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sidney Kimmel Cancer Center at Thomas Jefferson University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Wenyin Shi, MD
Principal Investigator Affiliation	Thomas Jefferson University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, WHO Grade II Glioma, WHO Grade III Glioma
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: Treatment (IM-SRT)

Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks.

Interventions

Radiation: - Intensity-Modulated Radiation Therapy

Undergo IM-SRT

Other: - Quality-of-Life

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Philadelphia, Pennsylvania

Status

Recruiting

Address

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Site Contact

David Andrews, MD

[email protected]

215-955-7000

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