NCT03611205

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2019

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

July 2, 2018

Last Update Submit

August 5, 2019

Conditions

Oropharyngeal Squamous Cell CarcinomaHPV Positive Oropharyngeal Squamous Cell Carcinoma

Keywords

OropharyngealSquamous Cell CarcinomaHPV

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 2 years

Secondary Outcomes (6)

  • Tumor burden

    Up to 2 years

  • Response rate for each patient local control

    At 2 years

  • Progression-free survival (PFS)

    Up to 2 years

  • Standard uptake volume (SUV) from digital/conventional PET

    At 3 months

  • Metabolic tumor volume (MTV) from digital/conventional PET

    At 3 months

  • +1 more secondary outcomes

Study Arms (1)

Diagnostic (dPET/CT)

EXPERIMENTAL

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.

Procedure: Computed TomographyProcedure: Positron Emission Tomography

Interventions

Computed TomographyPROCEDURE

Undergo dPET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Diagnostic (dPET/CT)
Positron Emission TomographyPROCEDURE

Undergo dPET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (dPET/CT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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:
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckCarcinoma, Squamous Cell

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Eric Miller, MD, PhD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 2, 2018

First Posted

August 2, 2018

Study Start

July 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share