Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-01 @ 6:10 AM
Study NCT ID:
NCT03611205
Status:
WITHDRAWN
Last Update Posted:
2019-08-07
First Post:
2018-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interim Digital PET/CT in Predicting Outcomes for Participants With Locally Advanced Oropharyngeal Cancer Undergoing Chemoradiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'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'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-05', 'studyFirstSubmitDate': '2018-07-02', 'studyFirstSubmitQcDate': '2018-07-31', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative assessments of digital positron emission tomography (dPET) characteristics generated at early time points during treatment', 'timeFrame': 'Up to 2 years', 'description': 'For each of the promising dPET parameters identified in the primary analysis we will examine potential cut-points to be used to best predict 6-month response/non-response using receiver operating characteristic (ROC) methods. Here we will examine specificity, sensitivity, positive predictive value and negative predictive values for each promising parameter to allow for preliminary data to be generated to anticipate which parameters may warrant future study.'}], 'secondaryOutcomes': [{'measure': 'Tumor burden', 'timeFrame': 'Up to 2 years', 'description': 'Will compare digital versus conventional PET. Comparison of PET parameters from the dPET or the conventional (c)PET will be visualized using scatterplots; agreement between the two methods will be summarized.'}, {'measure': 'Response rate for each patient local control', 'timeFrame': 'At 2 years', 'description': 'Will be defined as no evidence of disease at 6 months on physical and endoscopic exam for patient with a compete response on 3 month PET. Will be performed using Kaplan-Meier methods.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 2 years', 'description': 'PFS will be performed using Kaplan-Meier methods.'}, {'measure': 'Standard uptake volume (SUV) from digital/conventional PET', 'timeFrame': 'At 3 months', 'description': 'Will assess SUV and will compare mean values for each interim dPET. The changes of dPET/cPET SUV over the study period will be visualized using longitudinal plot, summarized at each time point, and modeled using linear mixed model for repeated measures.'}, {'measure': 'Metabolic tumor volume (MTV) from digital/conventional PET', 'timeFrame': 'At 3 months', 'description': 'Will assess MTV and will compare mean values for each interim dPET. The changes of dPET/cPET MTV over the study period will be visualized using longitudinal plot, summarized at each time point, and modeled using linear mixed model for repeated measures.'}, {'measure': 'Total lesion glycolysis (TLG) from digital/conventional PET', 'timeFrame': 'At 3 months', 'description': 'Will calculate TLG based on MTV and SUV and will compare mean values for each interim dPET. The changes of dPET/cPET TLG over the study period will be visualized using longitudinal plot, summarized at each time point, and modeled using linear mixed model for repeated measures.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oropharyngeal', 'Squamous Cell Carcinoma', 'HPV'], 'conditions': ['Oropharyngeal Squamous Cell Carcinoma', 'HPV Positive Oropharyngeal Squamous Cell Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': "This pilot trial studies how well interim digital positron emission tomography (PET)/computed tomography (CT) works in predicting outcomes in participants with oropharyngeal cancer that has spread from its original site of growth to nearby tissues or lymph nodes who are undergoing chemoradiation therapy. Diagnostic procedures, such as PET/CT may help measure a participant's response to treatment.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To evaluate the utility of early (i.e. during treatment) digital (d)PET as a diagnostic tool to predict local control 6 months after definitive chemoradiation for patients with locally advanced oropharyngeal carcinoma.\n\nSECONDARY OBJECTIVES:\n\nI. To study the association between dynamic dPET parameters taken at early time points (i.e. during treatment) and complete response (CR) on PET after definitive chemoradiation.\n\nII. To study the association between dynamic dPET parameters taken at early time points (i.e. during) treatment and 2 year LC after definitive chemoradiation.\n\nIII. To assess the ability of dynamic dPET compared to conventional PET or conventional-equivalent dPET reconstruction to identify tumor volumes with greater sensitivity at the time of before (dPET1), during (dPET2, dPET3) and after (dPET4, dPET5) chemoradiation.\n\nOUTLINE:\n\nParticipants receive radiotracer injection and undergo dPET/CT over 20-75 minutes at baseline, during the 2nd and 4th week of radiotherapy, and 3 months after the completion of chemoradiation therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who will undergo definitive radiation with concurrent chemotherapy with weekly (preferred) or high dose cisplatin for histologically confirmed locally advanced squamous cell carcinoma of the oropharyngeal carcinoma\n* Patient must have clinically or radiographically evident measurable disease at the primary site and at nodal station(s). Tonsillectomy or local excision of the primary or nodal disease is not permitted\n* P16 and/or human papillomavirus (HPV) status obtained on biopsy specimen\n* Low risk classification:\n\n * HPV positive, T1-3, N1-2b, M0 with =\\< 10 pack years smoking history\n * Note: Twenty cigarettes is considered equivalent to one pack.\n * Number of pack years = (number \\[No.\\] of cigarettes per day x number of years of smoking)/20 OR\n * Intermediate risk classification:\n\n * HPV positive, T4, N3, M0 and/or HPV positive with \\> 10 pack year smoking history\n * HPV negative, T1-3, N1-2b, M0, with =\\< 10 pack years smoking history OR\n * High risk classification: HPV negative, T4, N3, M0 and/or HPV negative with \\> 10 pack year smoking history\n* Patients with no contraindications to PET imaging or cisplatin as stated in the section Exclusion Criteria\n* No prior history of radiation therapy\n* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Patients with remaining teeth will have undergo a dental evaluation prior to enrollment\n* Ability to provide informed consent obtained prior to participation in the study and any related procedures being performed\n* Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the first administration of study treatment. Urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment.\n\nExclusion Criteria:\n\n* Prior cancers except non-melanoma skin cancer outside of the head and neck unless disease free for 5 years\n* Carcinoma of unknown primary, even if p16 positive\n* Clinical or radiologic evidence of metastatic disease as defined by disease below the clavicles\n* Simultaneous primary cancers or separate bilateral primary tumor sites with the exception of patients with bilateral tonsil cancers\n* Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* Medical contraindications to PET imaging (e.g. pregnancy, nursing mothers, weight greater than 420 pounds)\n* Medical contraindications to cisplatin or prior allergic reaction to cisplatin\n* Subjects who are unable to receive intravenous contrast due to a contrast allergy or poor renal function\n* Subjects who are prisoners\n* Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject?s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator. This could include severe, active co-morbidities such as:\n\n * Uncontrolled cardiac disease (hypertension, unstable angina, myocardial infarction within last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction)\n * Uncontrolled diabetes\n * Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration\n * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration'}, 'identificationModule': {'nctId': 'NCT03611205', 'briefTitle': 'Interim Digital PET/CT in Predicting Outcomes for Participants With Locally Advanced Oropharyngeal Cancer Undergoing Chemoradiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'A Pilot Study to Evaluate the Utility of Interim Digital PET/CT in Predicting Outcomes for Locally Advanced Oropharyngeal Cancer', 'orgStudyIdInfo': {'id': 'OSU-18030'}, 'secondaryIdInfos': [{'id': 'NCI-2018-01322', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'P30CA016058', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016058', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (dPET/CT)', 'description': 'Participants receive radiotracer injection and undergo dPET/CT over 20-75 minutes at baseline, during the 2nd and 4th week of radiotherapy, and 3 months after the completion of chemoradiation therapy.', 'interventionNames': ['Procedure: Computed Tomography', 'Procedure: Positron Emission Tomography']}], 'interventions': [{'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computerized Axial Tomography', 'computerized tomography', 'CT', 'CT SCAN', 'tomography'], 'description': 'Undergo dPET/CT', 'armGroupLabels': ['Diagnostic (dPET/CT)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging'], 'description': 'Undergo dPET/CT', 'armGroupLabels': ['Diagnostic (dPET/CT)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Eric Miller, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eric Miller', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}