Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 19 - Any |
Updated: | 6/14/2018 |
Start Date: | July 17, 2017 |
End Date: | January 1, 2022 |
Contact: | David Andrews, MD |
Email: | david.andrews@jefferson.edu |
Phone: | (215) 955-7000 |
Intensity-Modulated Stereotactic Radiotherapy as an Upfront Scalp-Sparing Intervention for the Treatment of Newly Diagnosed Grade II-IV Gliomas
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.
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.
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.
Inclusion Criteria:
- Patients must have histologically confirmed low or high grade glioma (grade II-IV)
- Karnosky 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
- Normal liver, kidney and bone marrow function
- 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
- Karnosky performance status (KPS) < 60
- Patient can't have magnetic resonance imaging (MRI) scan
- Active collagen vascular disease
We found this trial at
1
site
Philadelphia, Pennsylvania 19107
Phone: 215-955-7000
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