Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-27 @ 7:14 PM
Study NCT ID:
NCT01164566
Status:
TERMINATED
Last Update Posted:
2018-07-02
First Post:
2010-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esophagoscopy in Evaluating Treatment in Patients With Stage I-IV Head and Neck Cancer Who Are Undergoing Radiation Therapy and/or Chemotherapy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Inadequate Recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-29', 'studyFirstSubmitDate': '2010-07-07', 'studyFirstSubmitQcDate': '2010-07-15', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abnormal endoscopic esophageal examination', 'timeFrame': '3 months following completion of radiation therapy', 'description': "Abnormal endoscopic esophageal examination, as defined by presence of: stricture, web, ring, erosive esophagitis, fungal esophagitis, viral esophagitis, Barrett's metaplasia, neoplasm, or other."}], 'secondaryOutcomes': [{'measure': 'Severity of self-rated swallowing dysfunction', 'timeFrame': '3 months following completion of radiation therapy', 'description': 'Severity of self-rated swallowing dysfunction, as rated with the Eating Assessment Tool (0-40)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stage I Adenoid Cystic Carcinoma of the Oral Cavity', 'Stage I Mucoepidermoid Carcinoma of the Oral Cavity', 'Stage I Squamous Cell Carcinoma of the Hypopharynx', 'Stage I Squamous Cell Carcinoma of the Larynx', 'Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity', 'Stage I Verrucous Carcinoma of the Larynx', 'Stage I Verrucous Carcinoma of the Oral Cavity', 'Stage II Adenoid Cystic Carcinoma of the Oral Cavity', 'Stage II Mucoepidermoid Carcinoma of the Oral Cavity', 'Stage II Squamous Cell Carcinoma of the Hypopharynx', 'Stage II Squamous Cell Carcinoma of the Larynx', 'Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity', 'Stage II Verrucous Carcinoma of the Larynx', 'Stage II Verrucous Carcinoma of the Oral Cavity', 'Stage III Adenoid Cystic Carcinoma of the Oral Cavity', 'Stage III Mucoepidermoid Carcinoma of the Oral Cavity', 'Stage III Squamous Cell Carcinoma of the Hypopharynx', 'Stage III Squamous Cell Carcinoma of the Larynx', 'Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity', 'Stage III Verrucous Carcinoma of the Larynx', 'Stage III Verrucous Carcinoma of the Oral Cavity', 'Stage IV Adenoid Cystic Carcinoma of the Oral Cavity', 'Stage IV Mucoepidermoid Carcinoma of the Oral Cavity', 'Stage IV Squamous Cell Carcinoma of the Hypopharynx', 'Stage IV Squamous Cell Carcinoma of the Larynx', 'Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity', 'Stage IV Verrucous Carcinoma of the Larynx', 'Stage IV Verrucous Carcinoma of the Oral Cavity']}, 'descriptionModule': {'briefSummary': "Brief Summary:\n\nRATIONALE: Comparing results of diagnostic procedures, such as esophagoscopy, done before and after radiation therapy and/or chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.\n\nPURPOSE: This clinical trial is studying esophagoscopy in evaluating treatment in patients with stage I-IV head and neck cancer who are undergoing radiation therapy and/or chemotherapy.", 'detailedDescription': 'OBJECTIVES:\n\nI. To assess the prevalence of esophageal pathology (any esophageal abnormality, specifically: esophagitis, stricture/web, infections, neoplasms) as identified by esophagoscopy in patients with HNCA before and 3 months following primary radiation and/or chemotherapy.\n\nII. To assess the changes in self-reported dysphagia symptoms as measured by the Eating Assessment Tool.\n\nOUTLINE:\n\nPatients undergo transnasal esophagoscopy at baseline and 3 months following completion of radiation therapy and/or chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion\n\n* Written informed consent must be obtained from all participants prior to beginning therapy; participants should have the ability to understand and be willing to sign a written informed consent document\n* Primary diagnosis of head and neck carcinoma (oral, hypopharyngeal, laryngeal)\n* Stage I-IV, undergoing treatment with radiation therapy +/- chemotherapy\n\nExclusion\n\n* Medical history of esophageal dysfunction\n* Pregnant women are not excluded from participation'}, 'identificationModule': {'nctId': 'NCT01164566', 'briefTitle': 'Esophagoscopy in Evaluating Treatment in Patients With Stage I-IV Head and Neck Cancer Who Are Undergoing Radiation Therapy and/or Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Prospective Evaluation of Esophageal Pathology Treatment of Head and Neck Carcinoma', 'orgStudyIdInfo': {'id': 'IRB00012541'}, 'secondaryIdInfos': [{'id': 'NCI-2010-01466'}, {'id': 'CCCWFU 60110', 'type': 'OTHER', 'domain': 'Wake Forest University Health Sciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients undergo transnasal esophagoscopy at baseline and 3 months following completion of radiation therapy and/or chemotherapy.', 'interventionNames': ['Procedure: endoscopic procedure', 'Other: questionnaire administration']}], 'interventions': [{'name': 'endoscopic procedure', 'type': 'PROCEDURE', 'otherNames': ['endoscopy'], 'armGroupLabels': ['Arm I']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Catherine Rees', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}