GRID Therapy for Tumors of the Head, Neck, Thorax, Abdomen, Pelvis and Extremities.

Study Overview
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Brief Summary
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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.

Official Title
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ROR1903: Spatially Fractionated Radiation (Grid) Therapy for Tumors of the Head & Neck, Thorax, Abdomen, Pelvis, and Extremities

Conditions
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Radiation Therapy Complication, Tumor Neck, Tumor Abdomen

Intervention / Treatment
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* Radiation: Spatially Fractionated Radiation (GRID) Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Spatially Fractionated Radiation (GRID) Therapy|Grid therapy allows for high doses of radiation to be delivered over several spatially distinct, small regions. This permits regions of very high dose to a large tumor away from critical structures, which could be beneficial in both palliative and definitive treatments. Additionally, allowing for high doses to be delivered could pose a benefit for radioresistant histologies.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the local/radiographic control rate (per RECIST) in patients treated with GRID therapy. |  | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the adverse event profile (acute and late) of grid therapy by assessment of grade 3 or higher adverse events NCI-CTCAE v. 5 criteria. |  | through study completion, approximately 5 years | 
| Overall survival | Patient survival rate after grid therapy | through study completion, approximately 5 years | 
| Local/regional progression | Patient progression after grid therapy | through study completion, approximately 5 years | 
| Recurrence rate | Number of patients to have tumor recurrence after grid therapy | through study completion, approximately 5 years | 
| Distant disease control |  | through study completion, approximately 5 years | 
| Planning and delivery of grid therapy. | Total amount of time taken for planning and delivery of grid therapy | 5 years |