Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy
概览
- 阶段
- 不适用
- 干预措施
- Proton Radiation
- 疾病 / 适应症
- Brain Tumor
- 发起方
- Massachusetts General Hospital
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Duration of Local Control
- 状态
- 招募中
- 最后更新
- 17天前
概览
简要总结
This research study is studying Proton Radiation as a possible treatment for brain tumor.
The radiation involved in this study is:
-Proton Radiation
详细描述
The main purpose of this study is to see how well the tumor is responding to the Proton Radiation up to 5 years after the participant receive it. The investigators are also looking for how this type of radiation affects the quality of life as well as any type of side effect the participant may have after the radiation is administered. The FDA (the U.S. Food and Drug Administration) has not approved Proton Radiation for this specific disease but it has been approved for other uses.
研究者
Helen A. Shih, MD
Shih, Helen A, MD
Massachusetts General Hospital
入排标准
入选标准
- •Biopsy-proven benign or malignant brain tumor requiring tumor bed or tumor irradiation. This may include, but is not limited to, low-grade or favorable high-grade glioma, pituitary adenoma, vestibular schwannoma (acoustic neuroma), and meningioma as the most common diagnoses. Other tumor types that require irradiation and are deemed appropriate for proton radiation therapy are also eligible. Patients with a presumed diagnosis based on imaging and clinical characteristics will be permitted on this trial without pathological diagnostic confirmation if it is within standard of care to offer radiation therapy without a biopsy.
- •Participants must otherwise be indicated for proton radiation therapy
- •Age 18 years or older
- •Karnofsky performance status ≥ 60 (see Appendix A)
- •Participants may have had any extent of prior surgery and/or chemotherapy.
- •Must be able to speak and comprehend English
- •Ability to understand and willingness to sign a written informed consent document
- •The effects of proton radiation therapy on the developing human fetus are known to be teratogenic. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and 4 months after completion of proton therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study treatment, and 4 months after completion of proton therapy.
- •Life expectancy greater than or equal to 6 months.
排除标准
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant or lactating women are excluded from this study because radiation is known to have teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiation therapy, breastfeeding should be discontinued if the mother is treated with radiation therapy.
- •Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
研究组 & 干预措施
Proton Radiation
* Radiation therapy will be delivered typically five (5) days per week on weekdays * Proton Radiation dose be determine by histology
干预措施: Proton Radiation
结局指标
主要结局
Duration of Local Control
时间窗: 2 years
The duration of local control will be measured from the start date of protocol radiation until the date of progressive disease. Local control is defined as the lack of tumor growth as determined by a brain MRI (magnetic resonance imaging). This will include tumors that appear unchanged in size as compared to the baseline pre-radiation scan and also tumors that appear slightly reduced in size as may occur in response to radiation therapy. Inflammation secondary to radiation therapy can radiographically mimic subtle disease progression and may need to be confirmed with serial imaging. Progression is defined as an increase in the size of the tumor, a significant increase in T2/FLAIR non-enhancing lesion on sable or increasing doses of corticosteroids compared to baseline, the appearance of any new lesion, clear clinical deterioration not attributable to any other cause apart from the tumor, or failure to return for evaluation due to death or deteriorating condition.
次要结局
- Quality of Life Assessment EORTC-QLQ-C30(2 years)
- Neuroendocrine dysfunction(2 years)
- Vision Loss(2 years)
- Neurocognitive effects(2 years)
- Ototoxicity(2 years)
- CD4 count(2 years)
- Quality of Life Assessment HADS(2 Years)
- Quality of Life Assessment EORTC-QLQ-BN20(2 Years)
- Alopecia(2 years)