Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-25 @ 4:50 PM
Study NCT ID:
NCT03588403
Status:
UNKNOWN
Last Update Posted:
2018-07-20
First Post:
2018-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TOMO Versus IMRT in Nasopharyngeal Carcinoma Patients
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_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-18', 'studyFirstSubmitDate': '2018-07-04', 'studyFirstSubmitQcDate': '2018-07-16', 'lastUpdatePostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QoL(quality of life)', 'timeFrame': '2 years', 'description': 'Changes in quality of life were assessed by EORTC QLQ-C30'}], 'secondaryOutcomes': [{'measure': 'PFS (progression free survival)', 'timeFrame': '2 years', 'description': 'from the first day of therapy to the date of disease progression or death from any cause, whichever was first (according the criterion of RECIST 1.1 ).'}, {'measure': 'OS (overall survival)', 'timeFrame': '2 years', 'description': 'from the first day of therapy to death or last follow-up'}, {'measure': 'LRRFS(Locoregional failure-free survival)', 'timeFrame': '2 years', 'description': 'from the first day of therapy to the date of first locoregional relapse or until the date of the last follow-up visit.'}, {'measure': 'Adverse Events', 'timeFrame': '5 years', 'description': 'Participants will be followed for the duration of hospital stay, an expected average of 50 days and every 3 months thereafter for 5 years. Observe and record the toxicity profile (including but not limit to mucositis, liver and kidney function, et al.) according NCI-CTCAE 4.03 during the chemoradiation and follow-up.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Tomotherapy is a new radiation planning and delivery technology which may allow for delivery of higher radiation doses with less damage to normal tissues. The investigators aim to compare the treatment efficacy and quality of life between tomotherapy and intensity-modulated radiotherapy for patients with nasopharyngeal carcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'nasopharyngeal carcinoma patients staged T1-4N0-3M0', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with newly histologically confirmed non-keratinizing carcinoma.\n2. Tumor staged T1-4N0-3M0 （according to the 8th AJCC staging system）\n3. Performance status: KPS\\>70\n4. With normal liver function test (ALT, AST \\<1.5ULN)\n5. Renal: creatinine clearance \\>60ml/min\n6. Without hematopathy,marrow: WBC \\>4\\*109/L, HGB\\>80G/L, and PLT\\>100\\*109/L.\n7. Written informed consent\n\nExclusion Criteria:\n\n1. WHO type I squamous cell carcinoma or adenocarcinoma\n2. Age \\>65 or \\<18\n3. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)\n4. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)\n5. Patient is pregnant or lactating\n6. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \\>1.5×ULN), and emotional disturbance.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT03588403', 'briefTitle': 'TOMO Versus IMRT in Nasopharyngeal Carcinoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'Comparison of Tomotherapy Versus Intensity-modulated Radiotherapy for Patients With Nasopharyngeal Carcinoma: a Prospective,Phase II Study', 'orgStudyIdInfo': {'id': 'IRB-2018-133'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm A:Tomotherapy', 'description': 'Patients with non-disseminated nasopharyngeal carcinoma receiving Tomotherapy.The prescribed radiation dose was defined as follows: PGTVnx 7040cGy/32F,PGTVnd 7040cGy/32F,PTV1 6080cGy/32F,PTV2 5440cGy/32F.', 'interventionNames': ['Radiation: TOMO']}, {'label': 'Arm B: IMRT', 'description': 'Patients with non-disseminated nasopharyngeal carcinoma receiving IMRT.The prescribed radiation dose was defined as follows: PGTVnx 7040cGy/32F,PGTVnd 7040cGy/32F,PTV1 6080cGy/32F,PTV2 5440cGy/32F.', 'interventionNames': ['Radiation: IMRT']}], 'interventions': [{'name': 'TOMO', 'type': 'RADIATION', 'description': 'Tomotherapy', 'armGroupLabels': ['Arm A:Tomotherapy']}, {'name': 'IMRT', 'type': 'RADIATION', 'description': 'Intensity modulated radiotherapy', 'armGroupLabels': ['Arm B: IMRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaozhong Chen, MD', 'role': 'CONTACT', 'email': 'cxzfyun@sina.com', 'phone': '+86-571-88128202'}], 'facility': 'Xiaozhong Chen', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief phisician', 'investigatorFullName': 'Chen Xiaozhong', 'investigatorAffiliation': 'Zhejiang Cancer Hospital'}}}}