Using advanced radiation therapy to treat patients with gliomas
Intensity-Modulated Stereotactic Radiotherapy as an Upfront Scalp-Sparing Intervention for the Treatment of Newly Diagnosed Grade II-IV Gliomas
This study is testing a new type of radiation therapy for people with gliomas to see if it helps them recover better and have fewer side effects after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT03251027 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of intensity-modulated stereotactic radiation therapy (IM-SRT) in patients diagnosed with grade II-IV gliomas. The study aims to assess the impact of IM-SRT on various outcomes, including the incidence of wound infections, scalp thinning, hair loss, and overall quality of life. Patients will undergo treatment starting 3 to 8 weeks post-surgery, with careful monitoring of their recovery and side effects. The trial also includes imaging assessments to evaluate changes in scalp thickness.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed grade II-IV gliomas who have a Karnofsky performance status of 60 or higher.
Not a fit: Patients with prior scalp radiation, significant co-morbidities affecting wound healing, or those unable to undergo MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved recovery outcomes and quality of life for patients with gliomas.
How similar studies have performed: Previous studies have shown promising results with stereotactic radiation therapies, indicating potential for success in this novel application.
Eligibility criteria
Show full 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
Where this trial is running
Philadelphia, Pennsylvania
- Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Wenyin Shi, MD — Thomas Jefferson University
- Study coordinator: Wenyin Shi, MD
- Email: wenyin.shi@jefferson.edu
- Phone: (215) 955-6702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.