Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma (NCT03251027) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma
United States100 participantsStarted 2017-07-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying intensity-modulated stereotactic radiation therapy for gliomas ranging from Grade II to Grade IV, including glioblastoma — given my specific grade and diagnosis, is this type of radiation approach something worth discussing as an option for me?
2The trial is listed as 'active, not recruiting,' which means they are no longer enrolling new patients — does that mean there are other similar radiation trials currently open that I should be looking into instead?
3The main thing this trial is measuring is the rate of wound infection or wound dehiscence after this radiation technique — can you help me understand why wound complications are a concern with this approach, and how that risk compares to standard radiation treatments?
4Since this trial doesn't have a traditional phase listed, it may be designed more to assess safety and feasibility than to prove whether this treatment is more effective — does that affect how we should weigh it against established treatment options for my grade of glioma?
5Intensity-modulated stereotactic radiation is a highly precise technique — what does the treatment schedule typically look like in terms of the number of sessions and overall time commitment, and is that realistic given my current situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of wound infection or wound dehiscence
Timeframe: Up to 2 years
Trial details
NCT IDNCT03251027
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University