Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT03647527
Status:
UNKNOWN
Last Update Posted:
2018-08-27
First Post:
2018-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictor Analysis of Acute Radiation Oral Mucositis in NPC Patients Treated With IMRT/TOMO Combined Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-23', 'studyFirstSubmitDate': '2018-08-09', 'studyFirstSubmitQcDate': '2018-08-23', 'lastUpdatePostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the highest grade of oral mucositis', 'timeFrame': 'oral mucocitis will be checked every day during the date of initiation of radiation therapy until the date of completion of radiation therapy, the highest grade ≥ 3 define as severe oral mubocitis, assessed up to a month and a half', 'description': 'Radiation Therapy Oncology Group/European Organization for research and treatment acute radiation morbidity scoring criteria. Grade 0: No change over baseline, Grade 1: Injection/ may experience mild pain not requiring analgesic, Grade 2: Patchy mucositis which may produce an inflammatory serosanguinitis discharge/ may experience moderate pain requiring analgesia, Grade 3: Confluent fibrinous mucositis/ may include severe pain requiring narcotic, Grade 4: Ulceration, hemorrhage or necrosis, Grade 5: death (Higher score equals to worse outcome).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nasopharyngeal carcinoma', 'acute radiation oral mucositis', 'intensity modulated radiotherapy', 'tomography radiotherapy'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Radiation induced oral mucositis which may result in reduced quality of life is commonly seen during radiotherapy, especially combined with chemotherapy. This study is a prospective, single center, and exploratory study. Two contour methods of oral mucosal will be used in this study. All detail information will be recorded prospectively. The aim of this study is to explore predictive factors of acute radiotherapy induced oral mucositis in nasopharyngeal carcinoma patients treated with new precise radiotherapy (intensity modulated radiotherapy or tomography radiotherapy) by using different dosimetric parameters and clinically relevant variables.', 'detailedDescription': 'To prospectively identify the predictive value of different dosimetric parameters and assess the predictors of acute radiation oral mucositis in nasopharyngeal carcinoma patients treated with intensity modulated radiotherapy or tomography radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Between September 2016 and August 2018, consecutive patients with II-IVB nasopharyngeal carcinoma receiving intensity modulated radiotherapy or tomography radiotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.Clinical diagnosis of nasopharyngeal carcinoma. 2.7th version American Joint Committee on Cancer (AJCC) stage II-IVB. 3.Age must above 18. 4.Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group.\n\n5.Adequate bone marrow, renal, and hepatic function.\n\nExclusion Criteria:\n\n1. Treatment with palliative intent.\n2. Previous malignancy.\n3. Pregnancy or lactation.\n4. A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes.\n5. Any severe coexisting disease.'}, 'identificationModule': {'nctId': 'NCT03647527', 'briefTitle': 'Predictor Analysis of Acute Radiation Oral Mucositis in NPC Patients Treated With IMRT/TOMO Combined Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'Predictive Factor Analysis of Acute Radiation Oral Mucositis in Nasopharyngeal Carcinoma Patients Treated With Precise Radiotherapy Technique Combined Chemotherapy', 'orgStudyIdInfo': {'id': 'PF-AROM-NPC-IMRT/TOMO'}}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yuanyuan chen, Professor', 'role': 'CONTACT', 'email': 'chenyy@zjcc.org.cn', 'phone': '+86 13738103808'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Yuanyuan Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Chen yuanyuan', 'investigatorAffiliation': 'Zhejiang Cancer Hospital'}}}}