Interim Digital PET/CT in Predicting Outcomes for Participants With Locally Advanced Oropharyngeal Cancer Undergoing Chemoradiation Therapy
NCT ID: NCT03611205
Last Updated: 2019-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-07-01
2020-12-31
Brief Summary
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Detailed Description
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I. 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.
SECONDARY OBJECTIVES:
I. 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.
II. To study the association between dynamic dPET parameters taken at early time points (i.e. during) treatment and 2 year LC after definitive chemoradiation.
III. 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.
OUTLINE:
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (dPET/CT)
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.
Computed Tomography
Undergo dPET/CT
Positron Emission Tomography
Undergo dPET/CT
Interventions
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Computed Tomography
Undergo dPET/CT
Positron Emission Tomography
Undergo dPET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* P16 and/or human papillomavirus (HPV) status obtained on biopsy specimen
* Low risk classification:
* HPV positive, T1-3, N1-2b, M0 with =\< 10 pack years smoking history
* Note: Twenty cigarettes is considered equivalent to one pack.
* Number of pack years = (number \[No.\] of cigarettes per day x number of years of smoking)/20 OR
* Intermediate risk classification:
* HPV positive, T4, N3, M0 and/or HPV positive with \> 10 pack year smoking history
* HPV negative, T1-3, N1-2b, M0, with =\< 10 pack years smoking history OR
* High risk classification: HPV negative, T4, N3, M0 and/or HPV negative with \> 10 pack year smoking history
Exclusion Criteria
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patients with remaining teeth will have undergo a dental evaluation prior to enrollment
* Ability to provide informed consent obtained prior to participation in the study and any related procedures being performed
* 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.
* Prior cancers except non-melanoma skin cancer outside of the head and neck unless disease free for 5 years
* Carcinoma of unknown primary, even if p16 positive
* Clinical or radiologic evidence of metastatic disease as defined by disease below the clavicles
* Simultaneous primary cancers or separate bilateral primary tumor sites with the exception of patients with bilateral tonsil cancers
* 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
* Medical contraindications to PET imaging (e.g. pregnancy, nursing mothers, weight greater than 420 pounds)
* Medical contraindications to cisplatin or prior allergic reaction to cisplatin
* Subjects who are unable to receive intravenous contrast due to a contrast allergy or poor renal function
* Subjects who are prisoners
* 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:
* Uncontrolled cardiac disease (hypertension, unstable angina, myocardial infarction within last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction)
* Uncontrolled diabetes
* Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Eric Miller
Principal Investigator
Principal Investigators
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Eric Miller, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Related Links
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The Jamesline
Other Identifiers
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NCI-2018-01322
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-18030
Identifier Type: -
Identifier Source: org_study_id
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