Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT01864850
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2013-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non Inferiority Trial of Standard RT Versus Hypofractionated Split Course in Elderly Vulnerable Patients With HNSCC
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Radiotherapy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2013-05-21', 'studyFirstSubmitQcDate': '2013-05-29', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Locoregional control', 'timeFrame': '6 months', 'description': 'Patient alive with locoregional control at 6 months after the end of radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Acute toxicity', 'timeFrame': '3 months', 'description': 'Acute toxicity according to the CTC NCI V4 - rate of toxicity by type and by grade'}, {'measure': 'Late toxicity', 'timeFrame': '18 months', 'description': 'Late toxicity according to the RTOG late toxicity scale - rate of toxicity by type and by grade'}, {'measure': 'Autonomy', 'timeFrame': '18 months', 'description': 'Autonomy according to ADL scale'}, {'measure': 'Health related quality of life', 'timeFrame': '18 months', 'description': 'Quality of life according to EORTC QLQ-C30 and QLQ-HN35'}, {'measure': 'Overall survival', 'timeFrame': '18 months', 'description': 'Overall survival'}, {'measure': 'Locoregional progression', 'timeFrame': '18 months', 'description': 'Locoregional progression'}, {'measure': 'metastasis progression', 'timeFrame': '18 months', 'description': 'metastasis progression'}, {'measure': 'Progression free survival', 'timeFrame': '18 months', 'description': 'Progression free survival'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HNSCC', 'Elderly', 'Geriatry'], 'conditions': ['Head and Neck Squamous Cell Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.gortec.fr/', 'label': 'GORTEC'}]}, 'descriptionModule': {'briefSummary': 'Randomized comparison between standard radiotherapy and hypofractionated split course schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment, acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the same efficacy, measured by the locoregional control rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 70 or over\n* SIOG group 2 (vulnerable)\n* Life expectancy \\> 12 weeks\n* PS \\< 2\n* Histologically confirmed diagnosis of squamous cell carcinoma of head and neck: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown primary).\n* First line treatment\n* At least one measurable lesion (RECIST)\n* Stage II to IV\n* Patients unsuitable for surgery of the primary tumour: non resectable tumor, anesthesia contra indication, patient's refusal, or organ sparing approach. Cervical nodes dissection authorized\n* Patients planned to be treated in a curative intent with radiotherapy alone on primary tumor site and on at least one head and neck node area\n* Consent form signed\n\nExclusion Criteria:\n\n* Primary squamous cell carcinoma of sinus, the skin or of the salivary glands\n* Stage I cancer\n* Radiotherapy planned on primary tumor only, or on neck nodes only. For patients with metastatic lymph nodes from unknown primary head and neck squamous cell carcinoma, patients will be excluded if head and neck mucosa (oropharynx, larynx, hypopharynx) is not included as a target volume for radiotherapy\n* Prior radiotherapy of head and neck area\n* Concurrent chemotherapy or immunotherapy or hormonotherapy\n* Induction chemotherapy\n* Concomitant infection requiring IV antibiotics\n* cancer other than head and neck cancer within the previous 5 years (baso cellular skin carcinoma and cervix carcinoma excepted)\n* conditions that could lead to bad compliance"}, 'identificationModule': {'nctId': 'NCT01864850', 'acronym': 'ELAN-RT', 'briefTitle': 'Non Inferiority Trial of Standard RT Versus Hypofractionated Split Course in Elderly Vulnerable Patients With HNSCC', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Oncologie Radiotherapie Tete et Cou'}, 'officialTitle': 'Non Inferiority Randomized Trial of Standard Radiotherapy Versus Hypofractionated Split Course Radiotherapy in Elderly Vulnerable Patients With Inoperable Head and Neck Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'GORTEC ELAN-RT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard RT', 'description': '70 Gy / 7 weeks / 2 Gy per fraction', 'interventionNames': ['Radiation: Standard RT']}, {'type': 'EXPERIMENTAL', 'label': 'Hypofractionated RT', 'description': '55 Gy / 7 weeks with 2 weeks interruption / 3 Gy per fraction until 30 Gy, after interruption 2.5 Gy per fraction until 55 Gy', 'interventionNames': ['Radiation: Hypofractionated RT']}], 'interventions': [{'name': 'Standard RT', 'type': 'RADIATION', 'description': '70 Gy / 7 weeks / 2 Gy per fraction', 'armGroupLabels': ['Standard RT']}, {'name': 'Hypofractionated RT', 'type': 'RADIATION', 'description': '55 Gy / 7 weeks with 2 weeks interruption / 3 Gy per fraction until 30 Gy, after interruption 2.5 Gy per fraction until 55 Gy', 'armGroupLabels': ['Hypofractionated RT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '98 000', 'city': 'Monaco', 'country': 'Monaco', 'facility': 'Centre Hospitalier Princesse Grace', 'geoPoint': {'lat': 43.73718, 'lon': 7.42145}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data Monitoring Committee will meet every year either by a physical meeting or by conference call. Data on the recruitment, toxicity and autonomy are submitted every year.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Oncologie Radiotherapie Tete et Cou', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}