Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-02-28 @ 10:51 PM
Study NCT ID:
NCT02149602
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2014-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of Parotid-gland Sparing IMRT in Patients With Midline Tumour of the Head and Neck
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-26', 'studyFirstSubmitDate': '2014-05-26', 'studyFirstSubmitQcDate': '2014-05-26', 'lastUpdatePostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients reporting grade 2 or more xerostomia using subjective measure on the LENTSOMA late toxicity scoring scale one year after treatment.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Acute radiation toxicity', 'timeFrame': '0-3 months'}, {'measure': 'Late radiation toxicity', 'timeFrame': '3-24 months'}, {'measure': 'Survival outcomes for entire cohort and according to HPV status where available : Local control, Loco regional control, Loco-regional progression-free survival (LRPFS), Disease free survival, Overall survival.', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['involvement of bilateral parapharyngeal spaces'], 'conditions': ['Oropharyngeal Squamous Cell Cancer', 'Hypopharyngeal Squamous Cell Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a phase II trial designed to test the feasibility of delivering IMRT to head and neck cancer patients with tumours arising in the midline (oropharynx and hypopharynx), and to assess possible improvement in reducing the incidence of xerostomia with bilateral superficial lobe parotid sparing IMRT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Midline pharyngeal squamous cell cancers (excluding nasopharyngeal cancers)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed locally advanced HNSCC arising from the oropharynx or hypopharynx with high risk of bilateral parapharyngeal space involvement\n\nExclusion Criteria:\n\n* Patients \\<18 years old or with a previous malignancy other than non-melanomatous skin cancer'}, 'identificationModule': {'nctId': 'NCT02149602', 'acronym': 'PARSPORT-II', 'briefTitle': 'A Phase II Study of Parotid-gland Sparing IMRT in Patients With Midline Tumour of the Head and Neck', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'A Phase II Study of Parotid-gland Sparing Intensity-modulated Radiotherapy in Patients With Midline Tumour of the Head and Neck', 'orgStudyIdInfo': {'id': 'CCR 2588'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'oropharyngeal and hypopharyngeal HNSCC', 'description': 'Intensity Modulated Radiotherapy HPV positive and HPV negative', 'interventionNames': ['Radiation: Intensity modulated radiotherapy']}], 'interventions': [{'name': 'Intensity modulated radiotherapy', 'type': 'RADIATION', 'description': 'Bilateral superficial lobe parotid sparing intensity modulated radiotherapy', 'armGroupLabels': ['oropharyngeal and hypopharyngeal HNSCC']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW3 6JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Head and Neck Unit, Royal Marsden Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Christopher M Nutting, FRCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}