Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-02-25 @ 9:06 PM
Study NCT ID:
NCT03699969
Status:
UNKNOWN
Last Update Posted:
2018-10-11
First Post:
2018-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2018-10-05', 'studyFirstSubmitQcDate': '2018-10-05', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local control in the two arms', 'timeFrame': '33 months', 'description': 'Local control by RECIST criteria'}], 'secondaryOutcomes': [{'measure': 'The progression free survival in the two arms', 'timeFrame': '33 months', 'description': 'The time (in months) from the end of radiotherapy to the date of first progression'}, {'measure': 'The incidence of toxicity of radiotherapy by CTCAE protocol in the two arms', 'timeFrame': '33 months', 'description': 'The number of patients who develop radiotherapy toxicity as assessed by CTCAE protocol Version 4.0'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypofractionation', 'VMAT', 'head and neck cancer'], 'conditions': ['Locally Advanced Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'To compare efficacy and toxicity between hypofractionated dose escalated VMAT versus conventional concurrent chemoradiation in locally advanced head and neck cancer', 'detailedDescription': 'patients were randomized to receive either: 70Gy in 35fx in 7wks at 2Gy/fx concurrently with weekly cisplatin 40mg/m2 (Arm A) or 74Gy in 33 fractions (fx) in 6.5 weeks at 2.24Gy/fx (Arm B). Volumetric Modulated Arc Therapy (VMAT) plans were created for both treatment arms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years and ≤70 years old.\n2. Histopathologically confirmed squamous cell carcinoma of head and neck.\n3. Locally advanced tumors (T3-T4 \\&/or N1-3) (stage IIB, III and stage IV-A: Staging by AJCC 7th edition).\n4. Patients not exposed to radical surgery for current disease.\n5. Performance status (ECOG) 2 or less.\n6. No associated co-morbidity with contraindication to chemotherapy.\n7. Normal Hemogram. (ANC ≥1.5x109/L, Platelets count ≥100x109/L, hemoglobin ≥80 g/L)\n8. Accepted renal functions. (BUN \\& serum creatinine \\<1.5x upper limit of normal value with normal GFR).\n9. Accepted liver functions. (total bilirubin and direct bilirubin \\< 1.5 x ULN \\& alanine aminotransferase and aspartate aminotransferase \\< 3 x ULN)\n10. Informed consent.\n\nExclusion Criteria:\n\n1. Patients with distant metastatic lesions, as detected by imaging techniques.\n2. Patients with history of other head and neck malignancies.\n3. Patients with history of previous head and neck irradiation.\n4. Patients with a serious concomitant illness, such as active cardiac disease, severe uncontrolled hypertension, or uncontrolled infection.\n5. Women who are pregnant or breast feeding.'}, 'identificationModule': {'nctId': 'NCT03699969', 'briefTitle': 'A Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'A Clinical Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'HN12016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypofractionated dose escalated VMAT', 'description': 'Hypofractionated dose escalated VMAT radiotherapy', 'interventionNames': ['Radiation: Hypofractionated dose escalated VMAT']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional concurrent chemoradiation', 'description': 'Conventional concurrent chemoradiation'}], 'interventions': [{'name': 'Hypofractionated dose escalated VMAT', 'type': 'RADIATION', 'description': 'measure the local control, progression free survival and overall survival', 'armGroupLabels': ['Hypofractionated dose escalated VMAT']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ehab Saad', 'investigatorAffiliation': 'Cairo University'}}}}