Spatially Fractionated Radiation (Grid) Therapy for Tumors of the Head & Neck, Thorax, Abdomen, Pelvis, and Extremities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Local/radiographic control rate
研究概览
简要总结
This study is an observational registry study evaluating the clinical outcomes of grid therapy. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this study. Once consent has been obtained, baseline adverse event and QOL data will be collected and subjects will undergo grid therapy and follow-up at 2-4 weeks (for toxicity), and 3-6 months (for toxicities and radiographic control) then per clinical discretion up to 1 year. Patients will be evaluated according to the physician's standard practice and discretion. Patient data will be drawn from the patients' medical records and reported by means of a web-based electronic data collection (EDC) system. Patients will be considered "on study" until 60 months of observation has occurred, withdrawal of consent, lost to follow-up, or study closure. See below for the clinical visit flowchart for data collected at baseline and standard clinic visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with tumors of the head and neck, thorax, abdomen, pelvis, and extremities.
- •Age ≥ 18 years.
- •Histological confirmation of oncologic diagnosis.
- •Completed oncologic imaging (per discretion of treating physician)
- •ECOG Performance Status 0-3
- •Ability to complete questionnaire(s) by themselves or with assistance.
- •Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
- •Provide informed written consent.
排除标准
- •Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
- •Pregnant women
- •Nursing women
- •Women of childbearing potential who are unwilling to employ adequate contraception
- •Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- •Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy. NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
- •Uncontrolled inter-current 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.
结局指标
主要结局
Local/radiographic control rate
时间窗: 3-6 months
Assessed according to Response Evaluation Criteria In Solid Tumors (RECIST), a standard system to measure how cancer responds to different treatments, including chemotherapy, immunotherapy, and radiation therapy. The local/radiographic control rate will be estimated overall and by palliative/definitive patient status in patients treated with grid therapy.
次要结局
- To describe the adverse event profile (acute and late) of grid therapy by assessment of grade 3 or higher adverse events(through study completion, approximately 5 years)
- Planning and delivery of grid therapy.(5 years)
- Distant disease control(through study completion, approximately 5 years)
- Overall survival after grid therapy(through study completion, approximately 5 years)
- Local/regional progression after grid therapy(through study completion, approximately 5 years)
- Recurrence rate(through study completion, approximately 5 years)
研究者
Dawn M. Owen, M.D., Ph.D.
Principal Investigator
Mayo Clinic