Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 10:47 AM
Study NCT ID:
NCT00347256
Status:
WITHDRAWN
Last Update Posted:
2008-12-10
First Post:
2006-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010255', 'term': 'Paranasal Sinus Neoplasms'}], 'ancestors': [{'id': 'D009669', 'term': 'Nose Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D000094463', 'term': 'Transurethral Resection of Bladder'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'lastUpdateSubmitDate': '2008-12-09', 'studyFirstSubmitDate': '2006-06-29', 'studyFirstSubmitQcDate': '2006-06-29', 'lastUpdatePostDateStruct': {'date': '2008-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local control of cancer at two years post treatment'}, {'measure': 'Response to preoperative chemoradiation'}], 'secondaryOutcomes': [{'measure': 'Estimation of the proportion of the inoperable tumors which become operable after chemoradiation'}, {'measure': 'Identification of factors that are associated with inoperability'}, {'measure': 'Estimation of the overall survival and cumulative incidence of death due to disease at 2 years'}, {'measure': 'Determination of the acute and long-term toxicity, particularly ophthalmologic complications, and surgical morbidity associated with this regimen'}, {'measure': 'Measurement of the accuracy of conventional imaging techniques (CT, MRI) compared with the addition of PET imaging in predicting the response to chemoradiation therapy.'}]}, 'conditionsModule': {'conditions': ['Paranasal Sinus Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nasbs.org', 'label': 'North American Skull Base Society webpage'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of concurrent chemotherapy and radiotherapy pre-operatively in patients with advanced paranasal sinus cancer. The main objectives of this study are: 1) to measure the rate of complete response to preoperative chemoradiation and 2) to study the efficacy of combining preoperative chemoradiation and surgery in terms of local control of the cancer two years post treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Karnofsky Performance Score: \\>= 60\n* Creatinin clearance \\>= 50 ml/min or serum creatinine =\\<1.5 mg/dl\n* Total bilirubin, AST, ALT =\\< 1.5 X laboratory uln\n* ANC \\>= 2000/mm3, platelets \\>= 100,000/mm3\n* Serum calcium within normal range\n* T3 or T4 state tumors of paranasal sinuses\n* Squamous cell carcinoma, adenocarcinoma, high-grade mucoepidermoid carcinoma, sinonasal undifferentiated carcinoma\n\nExclusion Criteria:\n\n* History of other malignancy in the last 3 years\n* Other serious comorbidity that may significantly reduce the survival in next 5 years\n* Pregnant or lactating women\n* History of radiation to the head and neck region\n* Paranasal sinus tumor is recurrent after prior treatment\n* Presence of cervical node metastasis\n* Presence of distant metastasis\n* Advanced nasopharyngeal malignancy with sphenoid or posterior ethmoid invasion'}, 'identificationModule': {'nctId': 'NCT00347256', 'briefTitle': 'Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee'}, 'officialTitle': 'Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma', 'orgStudyIdInfo': {'id': 'NASBS-PNS001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'targeted radiation therapy', 'type': 'PROCEDURE'}, {'name': 'tumor resection', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sandeep Samant, MS, FRCS', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Tennessee'}, {'name': 'Sandeep Samant, MS, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tennessee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee', 'class': 'OTHER'}, 'collaborators': [{'name': 'North American Skull Base Society', 'class': 'OTHER'}]}}}