Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-01 @ 4:00 PM
Study NCT ID:
NCT07044635
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shortened Course of Radiation Therapy After Trans-oral Robotic Surgery in Patients With HPV-Mediated Oropharyngeal Squamous Cell Carcinoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stable or improved FACT-HN at 6 months post-treatment compared to baseline.', 'timeFrame': '2 years', 'description': 'To evaluate if a shorter course of therapy can improve quality of life in patients receiving adjuvant radiation therapy after TORS.'}], 'secondaryOutcomes': [{'measure': 'The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.', 'timeFrame': '2 years', 'description': 'To assess the safety and tolerability of reduced-dose adjuvant radiation therapy in the study population.'}, {'measure': 'The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).', 'timeFrame': '2 years', 'description': 'To assess the safety and tolerability of reduced-dose adjuvant radiation therapy in the study population.'}, {'measure': 'The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.', 'timeFrame': '2 years', 'description': 'To assess the safety and tolerability of reduced-dose adjuvant radiation therapy in the study population.'}, {'measure': 'The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.', 'timeFrame': '2 years', 'description': 'To assess the safety and tolerability of reduced-dose adjuvant radiation therapy in the study population.'}, {'measure': 'The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study drug.', 'timeFrame': '2 years', 'description': 'To assess the safety and tolerability of reduced-dose adjuvant radiation therapy in the study population.'}, {'measure': 'Progression-free survival (PFS) as defined as the time from surgery to the time of recurrence or death from any cause.', 'timeFrame': '4 years', 'description': 'To assess PFS at 1-year post-radiation.'}, {'measure': 'Overall survival (OS) as defined as the time from registration until death from any cause.', 'timeFrame': '4 years', 'description': 'To assess overall survival in this study population.'}, {'measure': 'The proportion of participants who experience local-regional recurrence.', 'timeFrame': '4 years', 'description': 'To assess the local-regional recurrence rate.'}, {'measure': 'The proportion of participants who experience distant recurrence.', 'timeFrame': '4 years', 'description': 'To assess the distant recurrence rate.'}, {'measure': 'The proportion of participants who experience recurrence.', 'timeFrame': '4 years', 'description': 'To assess the overall recurrence rate.'}, {'measure': 'Stable or improved MDADI defined by patient quality of life.', 'timeFrame': '4 years', 'description': 'To assess patient-reported quality of life.'}, {'measure': 'Stable or improved FACT-HN at 12 months post-treatment compared to baseline.', 'timeFrame': '4 years', 'description': 'To evaluate if a shorter course of therapy can improve quality of life in patients receiving adjuvant radiation therapy after TORS.'}, {'measure': 'This endpoint is restricted to participants who are able to work prior to treatment. Of those participants, the proportion who remain able to work 6 months after treatment as assessed by the FACT-HN.', 'timeFrame': '4 years', 'description': 'To evaluate the ability for participants to return to work after a shorter course of adjuvant radiation therapy following TORS.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Oropharyngeal Squamous Cell Carcinoma', 'HPV-mediated Oropharyngeal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate if a shorter course of therapy can improve the quality of life in patients receiving radiation therapy after trans-oral robotic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Step 1 Registration: Pre-Operative Eligibility\n\nInclusion Criteria:\n\n* Participant aged ≥ 18 years.\n* Diagnosis of oropharyngeal squamous cell carcinoma.\n* Eligible to receive transoral robotic surgery.\n* P16 positivity or HPV positivity by in situ hybridization on pathological sampling of lymph node or primary oropharyngeal tumor.\n* Pre-operative TTMV-HPV DNA test collected.\n\n * Standard of care tests completed within 60 days of registration may be used for screening.\n * Tests results are not required to confirm eligibility for step 1 registration.\n* ECOG Performance Status ≤ 2\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\n* History of prior mucosal head and neck cancer treated with radiation therapy\n* Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this study\n* Participant has smoked cigarettes within 1 month of registration\n* Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.\n* Known distant metastatic disease.\n* Current evidence of any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, \\[participants may not receive the drug through a feeding tube\\], social/ psychological issues, etc.)\n* Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.\n\nStep 2 Registration - Experimental Arm\n\nInclusion Criteria:\n\n* Completion of trans-oral robotic surgery.\n* Pre- and post-operative TTMV-HPV DNA test results obtained.\n* For participants of child bearing potential: Negative pregnancy test or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n * \\< 50 years of age:\n\n * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n * ≥ 50 years of age:\n\n * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n * Had radiation-induced menopause with last menses \\>1 year ago; or\n * Had chemotherapy-induced menopause with last menses \\>1 year\n* Participants of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.5.2.\n\nExclusion Criteria:\n\n* Meets ALL of the following criteria for low-risk disease (Note: participants may meet some without being excluded):\n\n * Pre-operative TTMV-HPV DNA positive\n * Post-operative TTMV-HPV DNA negative\n * Disease: pT1 with ≤ 1 lymph nodes OR pT2N0\n * \\<10 pack year smoking\n * No extranodal extension\n * Negative surgical margins\n * No perineural invasion\n * No lymphovascular invasion\n* Meets ANY of the following criteria for high-risk:\n\n * Post-operative TTMV-HPV DNA positive\n * Surgical margin positive --\\>1 mm extranodal extension --≥ 5 lymph nodes\n* Current evidence of any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, \\[participants may not receive the drug through a feeding tube\\], social/ psychological issues, etc.)"}, 'identificationModule': {'nctId': 'NCT07044635', 'acronym': 'RAD RAPTORS', 'briefTitle': 'Shortened Course of Radiation Therapy After Trans-oral Robotic Surgery in Patients With HPV-Mediated Oropharyngeal Squamous Cell Carcinoma.', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Radiation Therapy in Reduced Dose and Hypofractionated Schedule After Trans-Oral Robotic Surgery in Intermediate Risk HPV-Mediated Oropharyngeal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'HCI191152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10 fractions of radiation therapy', 'interventionNames': ['Radiation: Radiation Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radiation therapy with chemotherapy, if applicable, per standard of care', 'interventionNames': ['Radiation: Radiation Therapy']}], 'interventions': [{'name': 'Radiation Therapy', 'type': 'RADIATION', 'description': 'Reduced dose and Hypofractionated radiation therapy', 'armGroupLabels': ['10 fractions of radiation therapy', 'Radiation therapy with chemotherapy, if applicable, per standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Kingsford', 'role': 'CONTACT', 'email': 'rachel.kingsford@hci.utah.edu', 'phone': '801-585-0115'}, {'name': 'Shane Lloyd', 'role': 'CONTACT', 'email': 'shane.lloyd@hci.utah.edu', 'phone': '801-585-0255'}], 'facility': 'Huntsman Cancer Institute/University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Rachel Kingford', 'role': 'CONTACT', 'email': 'rachel.kingsford@hci.utah.edu', 'phone': '8015850115'}, {'name': 'Shane Lloyd', 'role': 'CONTACT', 'email': 'shane.lloyd@hci.utah.edu', 'phone': '801-585-0255'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}