[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463322":3},{"organization":4,"armGroups":7,"interventions":43,"overallOfficials":42,"centralContacts":49,"locations":56,"responsibleParty":73,"collaborators":42,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":42,"enrollmentInfo":84,"targetDuration":42,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":99,"overallStatus":58,"whyStopped":42,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"The New York Proton Center","OTHER",[8,14,18,22,26,30,34,38],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: Central Nervous System","EXPERIMENTAL","Group 1 Definitive Reirradiation Phase II\n\n* Patients w\u002Fhistory of intracranial or spinal (extradural, intradural, and\u002For intramedullary) CNS tumors for which radiation therapy was prev. delivered either to gross disease or in the postoperative setting\n* Min. 6 month interval b\u002Fw RT courses\n* Overlap of prior RT field (50% IDL)\n* Subgroup analysis: receipt of surgery for recurrence\u002Fsecond IC tumor; concurrent ST; tumor histology\n\nGroup 2 CNS Reirradiation Registry\n\n* Patients for whom a repeat course of RT to the CNS is indicated for recurrent disease or secondary primary\n* Postop or intact setting\n* Min. 6 month interval b\u002Fw RT courses\n* Overlap of prior RT field (50% IDL)\n* Histologically\u002Fclinically documented recurrent CNS tumor (benign or malignant)\n* Glioblastoma (histologic or molecular including IDH wildtype)\n* Astrocytoma (molecular IDH1 mutant)\n* Oligodendroglioma (molecular 1p19q co deleted)\n* Meningioma\n* Ependymoma\n* Chordoma\u002Fchondrosarcoma",[13],"Radiation: Pencil Beam Scanning Proton Therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: Head\u002FNeck","Group 1 Full Dose Reirradiation Phase II\n\n* Patients w\u002Fhistory of HNC for which RT was delivered definitively, now with recurrence to h\u002Fn amenable to full dose reRT\n* Gross unresected disease or PORT 2\u002F2 RF\n* Received at least 40 Gy overlapping w\u002Fnew target region\n* Min. 6 month interval b\u002Fw RT courses\n* Overlap of prior RT field (50% IDL)\n* Subgroup analysis: surgery, HPV status, concurrent ST\n\nGroup 2 Early (\\\u003C6months for prior RT) Palliative H\u002FN ReRT Phase I\n\n* Patients w\u002Fhistory of HNC for which RT was delivered definitively\u002Fadjuvant setting, now with biopsy proven recurrence to h\u002Fn with indication for palliative RT\n* At least 30 Gy prior RT overlapping with new treatment volume\n* \\\u003C6 month interval between RT courses\n\nGroup 3 Head\u002FNeck ReRT Registry\n\n* Patients w\u002Fhistory of HNC for which RT was delivered now with recurrence\u002Fsecondary primary requiring reRT\n* Postop or definitive\n* Prior RT dose at least 30 Gy overlapping w\u002Fnew treatment volume\n* Min.6 month interval b\u002Fw RT courses",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3: Breast","Group 1 Partial Breast Reirradiation (Phase II)\n\n* Patients with a history of breast cancer s\u002Fp BCT, now with small (≤3cm), unicentric, ipsilateral breast cancer recurrence receiving repeat BCT\n* Node negative\n* Negative margins\n* No LVI\n* Lumpectomy cavity:whole breast \\\u003C30%\n* Minimum 1 year interval between RT courses\n\nGroup 2: Regional LN and Breast\u002FCW ReRT (Phase II)\n\n* Patients with a history of breast cancer s\u002Fp RT , now with recurrence or new primary with indication for reirradiation to the breast\u002Fchest wall and regional LN\n* Minimum 1 year interval between RT courses\n* Negative metastatic workup (PET\u002FCT or CT C\u002FA\u002FP + bone scan)\n* Excludes concurrent chemotherapy\n\nGroup 3: Breast Reirradiation Registry\n\n* Patients with a history of breast cancer s\u002Fp RT , now with recurrence or new primary breast cancer with indication for reirradiation\n* Some overlaps of dose with prior RT course\n* Negative metastatic workup (PET\u002FCT or CT C\u002FA\u002FP + bone scan)\n* Excludes concurrent chemotherapy",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort 4: Thoracic","Group 1: Definitive Reirradiation for Locally Advanced Disease\n\n* Single arm, prospective, phase II study\n* Patients with a history of lung cancer s\u002Fp definitive RT , now with local recurrence of new primary centrally located and w\u002FI 50% IDL of prior RT field\n* Definitive reRT concurrent systemic therapy\n* Adequate pulmonary function defined as an FEV1 of \\>35% (with or without bronchodilator) within 90 days prior to registration\n* Minimum 6 month interval between RT courses\n* Negative metastatic workup\n\nGroup 2: Thoracic Registry Study\n\n* Registry design\n* Patients with histologically confirmed thoracic malignancy (NSCLC, SCLC , mesothelioma, thymoma, carcinoid, intrathoracic sarcoma) with prior thoracic RT\n* Minimum 3 month interval between RT courses\n* Negative metastatic workup",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Cohort 5: Gastrointestinal","Group 1 Esophagus \\& GEJ Reirradiation Phase II\n\n* Patients w\u002Fhistory of E\u002FGEJ cancer s\u002Fp RT, now w\u002Frecurrent\u002Fnew primary nonmetastatic E\u002FGEJ cancer for which salvage RT is recommended\n* Negative metastatic workup\n\nGroup 2 Liver Reirradiation Phase II\n\n* Patients w\u002Fhistory of HCC, cholangiocarcinoma or liver mets (any histology), s\u002Fp prior EBRT, now with in field recurrence\u002Fnew primary\u002Fmet, for which definitive reRT is recommended\n* CTP A or B7\n* Excl. prev. Y 90\u002Fradioembolization\n* Allow prior TACE\n* Overlap w\u002F50% IDL prior RT\n* Adequate bone marrow function\n\nGroup 3 Lower GI Reirradiation Phase II\n\n* Patients w\u002Fhistory of rectal\u002Fanal cancer s\u002Fp RT now w\u002Frecurrent\u002Fnew primary nonmetastatic rectal\u002Fanal cancer for whom salvage RT is recommended +\u002F chemotherapy\n* Negative metastatic workup (PET\u002FCT or CT C\u002FA\u002FP)\n\nGroup 4 GI Reirradiation Registry\n\n•Patients w\u002Fhistologically document recurrent or new GI malignancy with prior history of RT w\u002Foverlap of current RT volume by the 50% IDL",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Cohort 6: Genitourinary","Group 1 Locally recurrent prostate cancer w\u002Fin prev. radiation field Phase II\n\n* Patients w\u002Frecurrent prostate adenocarcinoma w\u002Fin prev. irradiated field w\u002Findication for repeat course of radiation\n* Min. 1 year interval b\u002Fw RT courses\n* Prostate gland or recurrent tumor \\\u003C100 cc or 6 cm in largest dimension\n* No persistent grade 2+ toxicity from prior radiation\n* Negative metastatic workup (bone scan, CT scan or PSMA\u002Faxumin scan\n\nGroup 2 Regional prostate cancer recurrence adjacent to the previous field Phase II\n\n* Patients w\u002Frecurrent prostate adenocarcinoma beyond prior RT field (outside 50% IDL) but w\u002Fin pelvis)\n* Min.1 year interval b\u002Fw RT courses (EBRT or brachy)\n* No persistent grade 2+ toxicity from prior radiation\n\nGroup 3 Prostate Reirradiation Registry\n\n* Patients w\u002Frecurrent prostate adenocarcinoma (prostate gland, postop bed, or pelvi c LN) who require RT to the prostate or pelvis in the setting of prior pelvis RT\n* No DM\n* Concurrent chemotherapy excl.",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"Cohort 7: Gynecological","Group 1: Locally recurrent gynecological cancer within previous field\n\n* Single arm, prospective, phase II study design\n* Patients with history of gyn cancer for which definitive or adjuvant\u002Fsalvage PORT was given, now with recurrence within 50% IDL recommended for radiotherapy\n* At least 1 year between RT courses\n* No persistent grade 3+ toxicity from prior RT\n* Concurrent chemotherapy excluded\n* Uncontrolled or widely metastatic disease\n* Life expectancy \\>6 months",[13],{"label":39,"type":40,"description":41,"interventionNames":42},"Cohort 8: Registry","NO_INTERVENTION","* Registry design\n* Any cancer patient for whom RT is indicated in the setting of prior RT and do not meet eligibility criteria for other cohorts\n* Overlap of 50% IDL of current treatment volume with prior RT field",null,[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":42},"RADIATION","Pencil Beam Scanning Proton Therapy","Use of Pencil Beam Scanning Proton Therapy compared with historical outcomes using photon therapy for the reirradiation of recurrent or new primary malignancies",[9,15,19,23,27,31,35],[50],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},"Ryan Holder, BS","CONTACT","646-968-9055","387","research@nyproton.com",[57],{"facility":5,"status":58,"city":59,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","New York","10035","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-74.00597,40.71427,{"lat":67,"lon":66},[70],{"name":71,"role":52,"phone":72,"phoneExt":42,"email":55},"Isabelle Choi, MD","646-968-9060",{"type":74,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100463322","prospective-evaluation-of-pencil-beam-scanning-proton-therapy-for-previously-irradiated-tumors-100463322",false,"NCT05313191","Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors","ReRT","Inclusion Criteria:\n\n* Age 18 years\n* Patient provides study specific informed consent prior to study entry.\n* Documented history and physical exam within 90 days prior to registration.\n* ECOG PS 0, 1, or 2 within 90 days prior to registration\n\nExclusion Criteria:\n\n* Non malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up.\n* Prior invasive non study malignancy unless disease free for ≥ 3 years\n\n  * Non melanoma skin cancer, low risk prostate cancer, well differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible.\n* History of active connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum","ALL","18 Years",{"count":85,"type":86},1800,"ESTIMATED","INTERVENTIONAL",[89],"NA","The goal of this clinical research trial is to study the use of differing investigational doses and scheduling for Proton Therapy for tumors previously treated with radiation therapy. Generally, when patients are first treated for cancer with radiation therapy, they are treated with traditional photon (or x-ray) radiation therapy, which uses high-energy waves to kill tumor cells. In some cases, the cancer either returns or a new tumor can present in a different part of the body. With the usual radiation treatment, the photon beams travel all the way through the body. As a result, healthy tissues in front of and behind the tumor are exposed to radiation. Physicians who treat these cases where the tumor has returned often use a much lower dose of radiation to prevent patients from experiencing serious and long-term side-effects. This dose is often not strong enough to destroy the cancerous tumor. Alternatively, they may also treat a smaller area than would be indicated for complete tumor eradication, again in an attempt to prevent serious and long-term toxicities, but at the cost of optimally treating the cancer. Proton therapy, however, may offer a chance to safely deliver a more effective dose and volume of radiation as it is more targeted and can spare healthy tissues surrounding the tumor.\n\nThe reason we are conducting this research study is to look at whether Proton therapy can be a better way to treat reoccurring tumors in patients who have previously received radiation therapy to the same area, compared to treatment approaches used to date.",[92,93,94,95,96,97,98],"CNS Cancer","Head and Neck Cancer","GI Cancer","Gynecologic Cancer","Prostate Cancer","Thoracic Cancer","Breast Cancer",[100,101,102,103],"Reirradiation","Cancer","Proton Therapy","Radiation Therapy","2026-04-06",{"date":106,"type":107},"2026-04-13","ACTUAL",{"date":109,"type":107},"2022-01-24",{"date":111,"type":86},"2028-01",{"name":5,"class":6},1]