[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Covenant Health Cancer Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100531473","reduction-of-gastrointestinal-toxicity-in-prostate-cancer-by-proton-spot-placement-100531473",false,"NCT06200259","Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement","Inclusion Criteria:\n\n* Pathological proven diagnosis of prostatic adenocarcinoma\n* History and physical exam to establish clinical staging\n* Clinical stage T1-T2c (AJCC 7th edition)\n* Prostate specific antigen (PSA) \\\u003C 20 ng\u002FmL\n* Gleason Score ≤ 7\n* Eastern Cooperative Oncology Group (ECOG) Performance status 0-1\n* Patients must be 18 years of age or older\n* Willingness and ability to complete the International Prostate Symptom Score (IPSS) survey and Expanded Prostate Cancer Index Composite (EPIC) questionnaire\n\nExclusion Criteria:\n\n* Prior radiotherapy to the pelvic area\n* Prior prostate cancer therapy: cryotherapy or hyperthermia\n* Prior systemic therapy (chemotherapy) for prostate cancer\n* Regional lymph nodes (common iliac, external iliac, internal iliac, presacral) are a target of treatment\n* Active diverticulitis, ulcerative colitis, or Crohn's disease","MALE","18 Years",{"count":18,"type":19},500,"ESTIMATED","INTERVENTIONAL",[22],"NA","This purpose of this study is to examine the placement of proton spots during pencil beam scanning proton therapy for low and intermediate risk prostate cancer. The researchers will test a unique technique called \"Spot Delete\" to control the placement of spots during treatment planning. They will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to rectal and bladder side effects. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body. The clinical team uses this CT scan to find the best placement for the protons. The \"Spot Delete\" method prevents protons from stopping in the rectum, sigmoid, and small bowel, which is thought to be related to acute or late toxicities, such as tenesmus, diarrhea, fecal incontinence, proctitis, and rectal hemorrhage.",[25,26,27],"Prostate Cancer","Prostate Adenocarcinoma","Prostate Carcinoma","RECRUITING","2025-12-16",{"date":31,"type":32},"2025-12-18","ACTUAL",{"date":34,"type":32},"2025-12-15",{"date":36,"type":19},"2040-01-02",{"name":38,"class":39},"Covenant Health Cancer Center","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":16,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":20,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":40},"100530168","evaluation-of-radiobiological-effects-in-skin-toxicities-head-and-neck-cancer-patients-with-pbs-proton-therapy-100530168","NCT06183268","Evaluation of Radiobiological Effects in Skin Toxicities Head and Neck Cancer Patients With PBS Proton Therapy","Evaluation of Radiobiological Effects in Skin Toxicities for Head and Neck Cancer Patients With Pencil Beam Scanning Proton Therapy","Inclusion Criteria:\n\n* The patient must consent to be in the study and must have signed an approved consent form conforming to federal and institutional guidelines.\n* Patients must be ≥ 18 years old.\n* Patient must have biopsy-proven squamous cell carcinoma, originating in the oral cavity, larynx, oropharynx, nasopharynx, or hypopharynx\n* Carcinoma of the neck of unknown primary site origin may be included if p16 positive\n* Clinical stage T1-2, N0-1, N2a-N3 or T3-4, any N (AJCC, 7th ed.), including no distant metastases\n* Patient can have prior surgical resection of a primary cancer in the head and neck at any previous time\n* Previous or concurrent chemotherapy is allowed\n* No serious health conditions as determined by physician that would impact ability to complete treatment or impact skin in the area of treatment\n\nExclusion Criteria:\n\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* Head and neck radiotherapy that does NOT include at least one cervical lymph node level (I, II, III, IV, or V) in the target volume.\n* Children\n* Women who are pregnant.","ALL",{"count":50,"type":19},100,[22],"This purpose of this study is to examine skin reactions (called radiation dermatitis) that occur during pencil beam scanning (PBS) proton therapy. The researchers will test a unique technique called \"Spot Delete\" to see if it can reduce skin reactions for head \\& neck patients treated with PBS. The investigators will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to these skin reactions. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body.",[54,55,56],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Head and Neck Carcinoma","2025-04-07",{"date":59,"type":32},"2025-04-08",{"date":61,"type":32},"2023-12-13",{"date":63,"type":19},"2030-01-02",{"name":38,"class":39},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":71,"minAge":16,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":20,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":40},"100516614","evaluation-of-radiobiological-effects-in-skin-toxicities-for-breast-cancer-patients-with-pencil-beam-scanning-proton-therapy-100516614","NCT06006806","Evaluation of Radiobiological Effects in Skin Toxicities for Breast Cancer Patients With Pencil Beam Scanning Proton Therapy","Inclusion Criteria:\n\n* The patient must consent to be in the study and must have signed an approved consent form conforming to federal and institutional guidelines.\n* Patients must be equal to or greater than 18 years old.\n* The patient must have stage 0, I, II, or III breast cancer\n* On histological examination, the tumor must be ductal carcinoma in-situ (DCIS) or invasive adenocarcinoma of the breast\n* Surgical treatment of the breast must have been lumpectomy or mastectomy\n* Patients must have an estrogen receptor (ER) analysis performed on the primary tumor\n* Progesterone (PgR) analysis is desired but not mandatory\n* No serious health conditions as determined by physician that would impact ability to complete treatment or impact skin in the area of treatment\n\nExclusion Criteria:\n\n* Stage IV breast cancer\n* Non-epithelial breast malignancies such as sarcoma or lymphoma\n* Paget's disease of the nipple\n* Prior breast or thoracic radiation therapy (RT) for any condition.\n* Collagen vascular disease, specifically dermatomyositis with a Creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.\n* Pregnancy or lactation\n* Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.","FEMALE",{"count":50,"type":19},[22],"This purpose of this study is to examine skin reactions (called radiation dermatitis) that occur during pencil beam scanning (PBS) proton therapy. The researchers will test a unique technique called \"Spot Delete\" to see if it can reduce skin reactions for breast patients treated with PBS. They will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to these skin reactions. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body. The clinical team uses this CT scan to find the best placement for the protons. The \"Spot Delete\" method prevents protons from stopping in the skin, which is thought to cause skin redness.",[76,77,78,79],"Breast Cancer","Breast Cancer Stage II","Breast Cancer Stage III","Breast Cancer Stage I",{"date":59,"type":32},{"date":82,"type":32},"2023-07-07",{"date":84,"type":19},"2030-07-07",{"name":38,"class":39},""]