Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT07197060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypofractionated Radiotherapy With 3.5 Gy Per Fraction for Early Glottic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-21', 'studyFirstSubmitDate': '2025-09-21', 'studyFirstSubmitQcDate': '2025-09-21', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'local control rate', 'timeFrame': '2-year', 'description': 'local control rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Early Glottic Cancer']}, 'descriptionModule': {'briefSummary': 'Early-stage glottic carcinoma (T1-T2N0M0) is typically managed with either transoral laser microsurgery or definitive radiotherapy, both providing excellent local control rates and voice preservation outcomes. Radiotherapy remains a widely adopted non-invasive option, particularly for patients with bilateral disease or poor surgical candidacy. Traditionally, conventional fractionation schemes of 2.0-2.25 Gy per fraction over 6-7 weeks have been standard; however, emerging evidence supports the use of hypofractionated radiotherapy (HFRT) as an effective and more convenient alternative in this setting.\n\nThe unique anatomical confinement of early glottic tumors, along with their low propensity for lymphatic spread, makes them ideal candidates for dose escalation using hypofractionation. Several retrospective and prospective studies have demonstrated that higher doses per fraction (2.5-3.5 Gy) can yield comparable or superior local control rates compared to conventional regimens, without significantly increasing toxicity. The incorporation of modern techniques such as Intensity Modulated RadioTherapy (IMRT) and Simultaneous Integrated Boost (SIB) has further.enabled safe and precise delivery of escalated doses to the primary lesion while sparing nearby organs-at-risk (OARs)\n\nRecent data have shown that a 3.5 Gy per fraction regimen (totaling 59.5 Gy in 17 fractions) achieves excellent tumor control with favorable toxicity profiles in selected patients. Additionally, omission of the posterior commissure from the elective target volume in the absence of direct tumor extension has been associated with reduced mucosal toxicity and improved patient-reported outcomes. Therefore,hypofractionated RT using 3.5 Gy per fraction offers a promising voice-preserving strategy in the treatment of early glottic cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with histologically confirmed squamous cell carcinoma of the glottisStage T1-T2N0M0 (AJCC 8th edition)based on clinical exam and imaging', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Histologically confirmed squamous cell carcinoma of the glottis\n\n * Stage T1-T2N0M0 (AJCC 8th edition)\n * (based on clinical exam and imaging)\n * Age ≥ 18 years\n * Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n * No prior radiotherapy or surgery to the larynx (except biopsy)\n * Adequate organ function and a life expectancy of at least 6 months\n * Ability to comply with follow-up schedule and complete voice assessments\n * Signed informed consent\n\nExclusion Criteria:\n\n* • Prior head and neck irradiation\n\n * Nodal involvement or distant metastasis\n * Poor vocal cord mobility or subglottic extension\n * Severe comorbidities or life expectancy \\< 6 months'}, 'identificationModule': {'nctId': 'NCT07197060', 'briefTitle': 'Hypofractionated Radiotherapy With 3.5 Gy Per Fraction for Early Glottic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Hypofractionated Radiotherapy With 3.5 Gy Per Fraction for Early Glottic Cancer', 'orgStudyIdInfo': {'id': 'Hypofractionated 3.5 Gy Gc'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group', 'description': 'Histologically confirmed squamous cell carcinoma of the glottis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'residant doctor at Assiut university hospital', 'investigatorFullName': 'Manar Tarek mohamed', 'investigatorAffiliation': 'Assiut University'}}}}