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Interim Digital PET/CT in Predicting Outcomes for Participants With Locally Advanced Oropharyngeal Cancer Undergoing Chemoradiation Therapy

Primary Purpose

Oropharyngeal Squamous Cell Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computed Tomography
Positron Emission Tomography
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Oropharyngeal Squamous Cell Carcinoma focused on measuring Oropharyngeal, Squamous Cell Carcinoma, HPV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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
  • Patients with no contraindications to PET imaging or cisplatin as stated in the section Exclusion Criteria
  • No prior history of radiation therapy
  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Diagnostic (dPET/CT)

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Quantitative assessments of digital positron emission tomography (dPET) characteristics generated at early time points during treatment
    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.

    Secondary Outcome Measures

    Tumor burden
    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.
    Response rate for each patient local control
    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.
    Progression-free survival (PFS)
    PFS will be performed using Kaplan-Meier methods.
    Standard uptake volume (SUV) from digital/conventional PET
    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.
    Metabolic tumor volume (MTV) from digital/conventional PET
    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.
    Total lesion glycolysis (TLG) from digital/conventional PET
    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.

    Full Information

    First Posted
    July 2, 2018
    Last Updated
    August 5, 2019
    Sponsor
    Ohio State University Comprehensive Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03611205
    Brief Title
    Interim Digital PET/CT in Predicting Outcomes for Participants With Locally Advanced Oropharyngeal Cancer Undergoing Chemoradiation Therapy
    Official Title
    A Pilot Study to Evaluate the Utility of Interim Digital PET/CT in Predicting Outcomes for Locally Advanced Oropharyngeal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI decision
    Study Start Date
    July 1, 2019 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ohio State University Comprehensive Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    PRIMARY OBJECTIVES: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oropharyngeal Squamous Cell Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma
    Keywords
    Oropharyngeal, Squamous Cell Carcinoma, HPV

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diagnostic (dPET/CT)
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Computed Tomography
    Other Intervention Name(s)
    CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
    Intervention Description
    Undergo dPET/CT
    Intervention Type
    Procedure
    Intervention Name(s)
    Positron Emission Tomography
    Other Intervention Name(s)
    Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
    Intervention Description
    Undergo dPET/CT
    Primary Outcome Measure Information:
    Title
    Quantitative assessments of digital positron emission tomography (dPET) characteristics generated at early time points during treatment
    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.
    Time Frame
    Up to 2 years
    Secondary Outcome Measure Information:
    Title
    Tumor burden
    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.
    Time Frame
    Up to 2 years
    Title
    Response rate for each patient local control
    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.
    Time Frame
    At 2 years
    Title
    Progression-free survival (PFS)
    Description
    PFS will be performed using Kaplan-Meier methods.
    Time Frame
    Up to 2 years
    Title
    Standard uptake volume (SUV) from digital/conventional PET
    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.
    Time Frame
    At 3 months
    Title
    Metabolic tumor volume (MTV) from digital/conventional PET
    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.
    Time Frame
    At 3 months
    Title
    Total lesion glycolysis (TLG) from digital/conventional PET
    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.
    Time Frame
    At 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 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 Patients with no contraindications to PET imaging or cisplatin as stated in the section Exclusion Criteria No prior history of radiation therapy 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. Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eric Miller, MD, PhD
    Organizational Affiliation
    Ohio State University Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    http://cancer.osu.edu
    Description
    The Jamesline

    Learn more about this trial

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