Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-02 @ 1:08 AM
Study NCT ID:
NCT04933357
Status:
UNKNOWN
Last Update Posted:
2021-06-21
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy 
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Loco-regional control of HNSCC patients.', 'timeFrame': '2 years loco-regional control.'}], 'secondaryOutcomes': [{'measure': 'Acute radiation toxicity', 'timeFrame': 'During treatment and up to 6 months post treatment.'}, {'measure': 'Comparison between different parameters of PET/CT and fMRI in assessing response to treatment.', 'timeFrame': '2-4 weeks after start of treatment'}, {'measure': 'Overall survival', 'timeFrame': '2 years overall survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective trial evaluating dose escalation using an SBRT boost to poor- responding tumors by interim functional imaging (PET/CT and fMRI) to improve the local control of HNCSCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than or equal to 18 years old. ECOG Performance Scale (0-2). Histological confirmation of SCC of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx.\n\nClinical stage II-IVB (AJCC, 8th edition). Multidisciplinary decision of radical radiation or concurrent chemoradiotherapy (CCRT).\n\nInformed consent obtained, signed and dated before specific protocol procedures.\n\nExclusion Criteria:\n\n* Stage I/II glottic cancer. Patients who underwent surgery for the primary tumor location. Distant metastases. Inability to undergo PET-CT or MRI. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease- free for a minimum of 5 years. Prior radiotherapy to the region of the head and neck that would result in overlap of radiation fields. Any psychological, familial, sociological or geographical condition that hamper compliance with the study and/ or follow up schedule.'}, 'identificationModule': {'nctId': 'NCT04933357', 'acronym': 'MART', 'briefTitle': 'Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy ', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy Using Functional Imaging', 'orgStudyIdInfo': {'id': 'RO2010-30912'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose escalation', 'interventionNames': ['Radiation: Dose escalation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard dose', 'interventionNames': ['Radiation: Standard dose']}], 'interventions': [{'name': 'Dose escalation', 'type': 'RADIATION', 'description': 'Dose escalation to poor responders to achieve dose equivalent more than 80 Gy using SBRT boost', 'armGroupLabels': ['Dose escalation']}, {'name': 'Standard dose', 'type': 'RADIATION', 'description': 'Standard dose to good responders to achieve dose equivalent of 70 Gy.', 'armGroupLabels': ['Standard dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Roa El-Tagy', 'role': 'CONTACT', 'email': 'roa.eltagy@gmail.com'}], 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Roa El-Tagy', 'role': 'CONTACT', 'email': 'roa.eltagy@gmail.com', 'phone': '002-01222410771'}, {'name': 'May Ashour', 'role': 'CONTACT', 'email': 'may25s@hotmail.com'}], 'overallOfficials': [{'name': 'Tarek Shouman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Roa AbdulRahim El-Tagy', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}