Clinical trial · Interventional
Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma
Intensity-Modulated Stereotactic Radiotherapy as an Upfront Scalp-Sparing Intervention for the Treatment of Newly Diagnosed Grade II-IV Gliomas
NCT03251027CI-TRIAL-00101682active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| WHO Grade II Glioma | WHO Grade 2 Glioma | ALIAS | 0.90 |
| WHO Grade III Glioma | WHO Grade 3 Glioma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Quality-of-Life | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (IM-SRT)
- description
- Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks.
- interventionNames
- Radiation: Intensity-Modulated Radiation Therapy
- Other: Quality-of-Life
Primary outcomes (1)
- measure
- Incidence of wound infection or wound dehiscence
- timeFrame
- Up to 2 years
- description
- Will assess the impact of intensity-modulated stereotactic radiotherapy (IM-SRT) on the incidence of wound infection, or wound dehiscence.
Secondary outcomes (4)
- measure
- Incidence of titanium implants
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNiazi M, Russial O, Cappelli L, Miller R, Chen Y, Vakhnenko Y, Liu H, Shi W. Efficacy of scalp-sparing volumetric-modulated arc therapy approach in reducing scalp radiation dose for patients with glioblastoma: a cross-sectional study. Chin Clin Oncol. 2023 Aug;12(4):36. doi: 10.21037/cco-23-15. PMID 37699601