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| ID | Type | Description | Link |
|---|---|---|---|
| JT 9581 | Other Identifier | JeffTrial Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (IM-SRT) | Experimental | Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity-Modulated Radiation Therapy | Radiation | Undergo IM-SRT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of wound infection or wound dehiscence | Will assess the impact of intensity-modulated stereotactic radiotherapy (IM-SRT) on the incidence of wound infection, or wound dehiscence. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of titanium implants | Will the impact of IM-SRT on the incidence of titanium implants as palpable cranial defects due to scalp thinning. Rates of titanium implant discomfort will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Scalp thickness | Will assess the IM-SRT on scalp thickness as determined by magnetic resonance imaging evaluations of scalp thickness in the coronal plane before conformal radiation therapy (XRT), at 9 months, and 18 months after XRT in the study group compared to time-matched historical controls of patients. Mixed effects linear regression will be used to jointly model scalp thickness measurements at pre-treatment, 9 months, and 18 months. Potential confounding factors (chemotherapy, smoking history, diabetes) will also be included in the model. The residual variance covariance matrix will be assumed to have a compound-symmetric structure to account for the correlation among repeated measurements. Linear contrasts will be used to compare the change from pre-treatment to 9 months between IM-SRT and conformal therapy patients and to compare the change from pre treatment to 18 months between IM-SRT and conformal therapy patients. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenyin Shi, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37699601 | Derived | Niazi 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. |
| Label | URL |
|---|---|
| Sidney Kimmel Cancer Center | View source |
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| Quality-of-Life |
| Other |
Ancillary studies |
|
|
| Incidence of hair loss | Will assess the impact of IM-SRT on the incidence of hair loss. Will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters. | Up to 2 years |
| Incidence of recovery rate | Will assess the impact of IM-SRT on the incidence of recovery rate. Will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters. | Up to 2 years |
| Quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire | Will assess the impact on quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire. Will be modeled using mixed effects linear regression. Within-cohort changes will be estimated using linear contrasts of model parameters. | Up to 2 years |
| Up to 18 months |
| Thomas Jefferson University Hospital | View source |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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