Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-02-10 @ 6:25 AM
Study NCT ID:
NCT05714657
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2022-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shortened Course Adjuvant Radiotherapy Following TORS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2022-08-03', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Locoregional control', 'timeFrame': '2 years', 'description': 'To determine whether disease recurs locally (at primary site) or in regionally in the nodes of the neck'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '2 Years', 'description': 'To determine progression-free survival (any progression)'}, {'measure': 'Metastasis-free survival', 'timeFrame': '2 years', 'description': 'To determine metastasis-free survival (any distant metastasis)'}, {'measure': 'Overall survival', 'timeFrame': '2 years', 'description': 'To determine overall survival (alive or not)'}, {'measure': 'Differences in toxicity between patients receiving IMRT and patients receiving PBT', 'timeFrame': '2 years', 'description': 'To assess toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.'}, {'measure': 'Patient-Reported Quality of Life using MDASI-HN', 'timeFrame': '2 years', 'description': 'The MD Anderson Symptom Inventory - Head \\& Neck (MDASI-HN)\n\n1. Minimum Value: 0\n2. Maximum Value: 280\n3. Higher scores mean worse outcome'}, {'measure': 'Patient-Reported Quality of Life using MDADI', 'timeFrame': '2 years', 'description': 'The MD Anderson Dysphagia Inventory (MDADI)\n\n1. Minimum Value: 20\n2. Maximum Value: 100\n3. Higher scores mean better outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HPV-Associated Oropharyngeal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, phase II study to establish the safety of reducing radiation dose in selected HPV-Associated OPSCC patients receiving adjuvant radiation after TORS and neck dissection. This protocol also allows for sparing of the primary resection bed, in appropriate patients, as previously published by our group and found to be safe and effective.', 'detailedDescription': 'This is a single-arm Phase II non-inferiority study of adjuvant radiation for locally-advanced HPV-Associated oropharyngeal squamous cell carcinoma. Patients with pT0-T3, N0-N1, M0 disease (per AJCC 8th Edition), detectable pre-operative and undetectable postoperative ctHPVDNA will be eligible. Patients will have undergone TORS primary site resection and neck dissection. Patients will undergo adjuvant RT +/- guideline-indicated chemotherapy. The neck and the primary site will be considered separately.\n\nThe primary objective of the study will be to determine the 2-year locoregional control (LRC) rate. Secondary objectives include measures of toxicity (as measured by CTCAE, version 5.0), patient-reported QOL (as measured by the MDASI and MDADI questionnaire), progression-free survival, metastasis-free survival, and overall survival. Differences between patients treated with IMRT and proton therapy in terms of toxicity and QOL will serve as another secondary objective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years old\n* Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry or HPV-positive by In-Situ Hybridization\n* Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 8th Ed)\n* Pathologic N0-N1 disease (per AJCC 8th Ed)\n* Preoperative plasma ctHPVDNA of ≥ 50 copies/mL\n* Undetectable postoperative plasma ctHPVDNA\n* ECOG Performance Status 0-1\n\nExclusion Criteria:\n\n* Prior external beam radiation therapy to the head and neck\n* Presence of T4 disease\n* ≥ 5 positive lymph nodes (which is pathologic N2 disease, per AJCC 8th edition)\n* Presence of distant metastatic disease\n* Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.'}, 'identificationModule': {'nctId': 'NCT05714657', 'briefTitle': 'Shortened Course Adjuvant Radiotherapy Following TORS', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'A Phase II Study of Shortened Course, Dose De-Intensified Adjuvant Radiotherapy Following Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'UPCC 06322'}, 'secondaryIdInfos': [{'id': '852738', 'type': 'OTHER', 'domain': 'University of Pennsylvania Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shortened Course Adjuvant Radiotherapy', 'description': 'The volume treated to the regional lymphatics will be according to the characteristics of the primary site and involved lymph nodes. The dose of radiotherapy delivered will be 30 Gy, over the course of 10 treatments (5 daily treatments/week).\n\nTreatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol. In patients requiring treatment of the primary site, reduced dose (30 Gy) will be delivered.', 'interventionNames': ['Radiation: Shortened Course Adjuvant Radiotherapy Following TORS']}], 'interventions': [{'name': 'Shortened Course Adjuvant Radiotherapy Following TORS', 'type': 'RADIATION', 'description': 'Shortened Course Adjuvant Radiotherapy Following TORS', 'armGroupLabels': ['Shortened Course Adjuvant Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17604', 'city': 'Lancaster', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alyson Eckert, RN', 'role': 'CONTACT', 'email': 'Alyson.Eckert@pennmedicine.upenn.edu', 'phone': '717-544-0511'}, {'name': 'Pamela Boimel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lancaster General Hospital', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Project Manager', 'role': 'CONTACT', 'email': 'RadOncCRU@PennMedicine.upenn.edu'}, {'name': 'Lin', 'role': 'CONTACT'}, {'name': 'Alexander Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Project Manager', 'role': 'CONTACT', 'email': 'RadOncCRU@PennMedicine.upenn.edu'}, {'name': 'Michelle Gentile, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Pennsylvania Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Project Manager', 'role': 'CONTACT', 'email': 'RadOncCRU@PennMedicine.upenn.edu', 'phone': '267-854-5332'}], 'overallOfficials': [{'name': 'Alexander Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}