Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 9:57 PM
Study NCT ID:
NCT06087861
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2023-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
5-Day Preoperative Radiation for Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2023-10-11', 'studyFirstSubmitQcDate': '2023-10-11', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative Complication Rate', 'timeFrame': '120 days after surgery', 'description': 'Rate of post-operative complications.'}], 'secondaryOutcomes': [{'measure': 'Local Recurrence Rate', 'timeFrame': '2 years and 5 years after surgical resection', 'description': 'Rate of local recurrence, including in-field, borderline and out-field recurrences'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Soft Tissue Sarcoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum.\n2. Has been offered preoperative radiation and surgery as part of standard-of-care treatment\n3. Age ≥ 18\n4. KPS ≥ 70 or ECOG 0 to 2\n5. Life expectancy ≥ 6 months\n6. If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented.\n7. Ability to understand and the willingness to personally sign the written IRB approved informed consent document.\n\nExclusion Criteria:\n\n1. History of prior radiation to the area to be treated.\n2. Active use of other anti-cancer investigational agents.\n3. Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery).\n4. Pregnancy.'}, 'identificationModule': {'nctId': 'NCT06087861', 'briefTitle': '5-Day Preoperative Radiation for Soft Tissue Sarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma', 'orgStudyIdInfo': {'id': 'IRB-71865'}, 'secondaryIdInfos': [{'id': 'NCI-2024-00868', 'type': 'REGISTRY', 'domain': 'NCI- Clinical Trials Reporting Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'External beam radiotherapy', 'description': 'Patients will receive treatment with external beam radiotherapy at a total of 30 Gy delivered over five fractions delivered daily.', 'interventionNames': ['Radiation: External Beam Radiotherapy']}], 'interventions': [{'name': 'External Beam Radiotherapy', 'type': 'RADIATION', 'description': 'Radiation will be delivered by external beam techniques to the tumor and areas of possible microscopic disease at a dose of 30 Gy divided into 5 equal fractions of 6 Gy (administered over a total of 5 to 10 business day', 'armGroupLabels': ['External beam radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alyssa Yauger', 'role': 'CONTACT', 'email': 'ayauger@stanford.edu', 'phone': '650-498-5271'}, {'name': 'Camellia Djebroun', 'role': 'CONTACT', 'email': 'cdjebrou@stanford.edu', 'phone': '650-736-5564'}, {'name': 'Anusha Kalbasi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Everett Moding', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Susie Hiniker', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Alyssa Yauger', 'role': 'CONTACT', 'email': 'ayauger@stanford.edu', 'phone': '650-498-5271'}, {'name': 'Camellia Djebroun', 'role': 'CONTACT', 'email': 'cdjebrou@stanford.edu', 'phone': '650-736-5564'}], 'overallOfficials': [{'name': 'Anusha Kalbasi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}