Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 2:46 AM
Study NCT ID:
NCT03810651
Status:
RECRUITING
Last Update Posted:
2025-04-27
First Post:
2019-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pencil Beam Scanning in Patients With Renal Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D009396', 'term': 'Wilms Tumor'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2019-01-15', 'studyFirstSubmitQcDate': '2019-01-17', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of any non-hematologic toxicity that occurs within 90 days following the start of proton therapy assessed with with NCI Common toxicity criteria (CTC Version 4.0) grades].', 'timeFrame': '90 days', 'description': 'Acute toxicity in patients receiving flank irradiation using proton therapy for renal tumors. Acute toxicity is defined as any non-hematologic toxicity that occurs within 90 days following the start of proton therapy. NCI Common toxicity criteria (CTC Version 4.0) grades will be employed. Individual category content listings are available to investigators at http://ctep.cancer.gov, with attention to the following System Organ Classes and CTCAE Adverse Events: General Disorders and Administration Site Conditions, Hepatobiliary Disorders, Blood and Lymphatic System Disorders, Gastrointestinal Disorders, Renal and Urinary Disorders, Injury, poisoning, or procedural complications, Metabolism and nutrition disorders, and Benign, Malignant, and Unspecified Neoplasms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Tumor', 'Wilms Tumor']}, 'descriptionModule': {'briefSummary': 'This is a pilot study to assess acute toxicity in patients receiving flank irradiation using proton therapy for renal tumors.', 'detailedDescription': 'Patients with renal tumors including Wilms and clear cell sarcoma of the kidney (CCSK) are treated with multimodality therapy which may include surgery, chemotherapy, and radiation. While long-term disease control is excellent, these patients remain at risk for early and late toxicities partially from radiation. There have been no significant changes to traditional photon radiation fields, which encompass the post-operative bed, anterior abdomen, and vertebral body. Proton beam radiation using pencil beam scanning, which is characterized by Bragg peak dose deposition and high conformality of dose to target regions, is ideally suited to treat the retroperitoneum. This pilot study evaluates pencil beam scanning proton therapy (PBS-PT) to:\n\n* result in low acute gastrointestinal toxicity in patients receiving radiation therapy for renal tumors as measured by laboratory evaluations, clinician-assessed, and patient reported health related quality of life outcomes\n* decrease the duration of radiation therapy\n* compare doses to organs at risk (OARs) using PBS-PT as compared to traditional photon fields'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Less than 30 years of age\n* Diagnosis\n\n a. Any patient with Wilms tumor or clear cell sarcoma of the kidney who would require radiation therapy as standard of care including\n 1. Any patient with favorable histology (FH), stage III disease\n 2. Any patient with focal or diffuse anaplasia\n 3. Any patient with CCSK\n* The patient is a candidate for external beam radiotherapy based on standard of care for treatment of Wilms tumor or CCSK\n\nExclusion Criteria:\n\n* Prior radiotherapy to the region of the study cancer\n* Chemotherapy administered for diagnosis of Wilms tumor or CCSK\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT03810651', 'briefTitle': 'Pencil Beam Scanning in Patients With Renal Tumors', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Pilot Study of Pencil Beam Scanning Proton Beam Radiation Therapy in Patients With Renal Tumors', 'orgStudyIdInfo': {'id': '17-014386'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Renal tumors', 'description': 'Any patient with Wilms tumor or clear cell sarcoma of the kidney who would require radiation therapy as standard of care. Patients may receive an investigation drug for Wilms or CCSK given concurrently or within the first four weeks of the first fraction of proton therapy administration.', 'interventionNames': ['Other: Proton beam radiation using pencil beam scanning']}], 'interventions': [{'name': 'Proton beam radiation using pencil beam scanning', 'type': 'OTHER', 'description': 'Proton beam radiation using pencil beam scanning, characterized by Bragg peak dose deposition and high conformality of dose to target regions', 'armGroupLabels': ['Renal tumors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Hill-Kayser, MD', 'role': 'CONTACT', 'email': 'hill@uphs.upenn.edu', 'phone': '215-590-2810'}, {'name': 'Ratnakar Patti', 'role': 'CONTACT', 'email': 'PATTIR@chop.edu'}], 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Christine Hill-Kayser, MD', 'role': 'CONTACT', 'email': 'hill@uphs.upenn.edu', 'phone': '215-590-2810'}, {'name': 'Ratnakar Patti', 'role': 'CONTACT', 'email': 'PATTIR@chop.edu'}], 'overallOfficials': [{'name': 'Christine Hill-Kayser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}