protocolSection identificationModule nctId: NCT06310655, orgStudyIdInfo id: 202403078, briefTitle: Online Proton Adaptive Radiotherapy, acronym: PARTy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-05-15, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, descriptionModule briefSummary: This is a pilot study evaluating the feasibility of daily online adaptive planning for patients undergoing proton radiation therapy.Patients undergoing proton radiation therapy normally undergo extensive pre-planning for their treatment. However, accounting for uncertainties in treatment delivery remains a challenge for a variety of reasons, such as differences in patient anatomy from pre-planning to the day of treatment. Online adaptive planning is a process consisting of generating the original pre-plan on the patient on a treatment day, assessing the pre-plan's coverage and safety, and if changes are needed, the plan is changed in order to optimize the treatment while the patient is still on the treatment table. This study is assessing the feasibility and safety of this approach in order to gather data for a larger trial., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All patients will receive 5 fractions of proton radiotherapy for their cancer. At the time of each fraction, the initial pre-plan will be compared to the newly generated adapted plan, and the optimal treatment will be administered., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Proton SBRT, outcomesModule primaryOutcomes measure: Feasibility of online proton adaptive radiotherapy, secondaryOutcomes measure: Safety of online proton adaptive radiotherapy as measured by the amount of grade 2 and higher radiation-related toxicities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Washington University School of Medicine, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Allen Mo, M.D., Ph.D., role: CONTACT, phone: 314-717-2320, email: amo@wustl.edu, contacts name: Allen Mo, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Hyun Kim, M.D., role: SUB_INVESTIGATOR, contacts name: Stephanie Perkins, M.D., role: SUB_INVESTIGATOR, contacts name: Joshua Schiff, M.D., role: SUB_INVESTIGATOR, contacts name: Weiren Liu, M.D., role: SUB_INVESTIGATOR, contacts name: Hailei Zhang, Ph.D., role: SUB_INVESTIGATOR, contacts name: Yi Huang, M.S., role: SUB_INVESTIGATOR, contacts name: Robbie Beckert, role: SUB_INVESTIGATOR, contacts name: Eric Laugeman, M.S., role: SUB_INVESTIGATOR, contacts name: Farideh Pak, Ph.D., role: SUB_INVESTIGATOR, contacts name: Mike Watts, M.S., role: SUB_INVESTIGATOR, contacts name: Xiandong Zhao, Ph.D., role: SUB_INVESTIGATOR, contacts name: Tianyu Zhao, Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, hasResults: False