Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVES:
- 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:
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To determine the effect of IM-SRT on the incidence of titanium implants as palpable cranial defects due to scalp thinning.
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To determine the effect of IM-SRT on the incidence of hair loss and recovery rate.
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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:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (IM-SRT) Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks. |
Radiation: Intensity-Modulated Radiation Therapy
Undergo IM-SRT
Other: Quality-of-Life
Ancillary studies
Other Names:
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Outcome Measures
Primary Outcome Measures
- Incidence of wound infection or wound dehiscence [Up to 2 years]
Will assess the impact of intensity-modulated stereotactic radiotherapy (IM-SRT) on the incidence of wound infection, or wound dehiscence.
Secondary Outcome Measures
- Incidence of titanium implants [Up to 2 years]
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.
- Incidence of hair loss [Up to 2 years]
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.
- Incidence of recovery rate [Up to 2 years]
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.
- Quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire [Up to 2 years]
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.
Other Outcome Measures
- Scalp thickness [Up to 18 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients must have histologically confirmed low or high grade glioma (grade II-IV)
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Karnofsky performance status (KPS) >= 60
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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
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Estimated survival >= 3 months
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Labs considered acceptable per standard of care
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Patient must sign a study specific informed consent form
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Radiation treatment must begin >= 3 weeks and =< 8 weeks after surgery
Exclusion Criteria:
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Prior history of scalp radiation or intolerance to standard course of radiation treatment
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Co-morbidities that would influence wound healing including diabetes (insulin dependent) or smoking (current ongoing use)
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Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
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Karnofsky performance status (KPS) < 60
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Patient can't have magnetic resonance imaging (MRI) scan
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Active collagen vascular disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
- Principal Investigator: Wenyin Shi, MD, Thomas Jefferson University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 17D.074