Digital PET Scan for the Prediction of Outcomes in Patients With Locally Advanced Oropharyngeal Cancer

The Ohio State University

Status

Withdrawn

Conditions

Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Locally Advanced Oropharyngeal Squamous Cell Carcinoma

Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Treatments

Radiation: Fludeoxyglucose F-18

Procedure: Positron Emission Tomography

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04140513

OSU-19172

NCI-2019-05315 (Registry Identifier)

Details and patient eligibility

About

This trial studies how well digital PET scan works in predicting outcomes in patients with oropharyngeal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). The development of digital detectors for PET is a technological improvement in medical imaging that could potentially impact many areas of clinical oncology, including staging, radiation planning accuracy, and the assessment of treatment response. Digital technology may improve PET imaging performance by providing better timing, energy and spatial resolution, higher count rate capabilities and linearity, increased contrast, and reduced noise. Utilizing digital PET scan, may work better in predicting outcomes and treatment response in patients with oropharyngeal cancer compared to conventional PET.

Full description

PRIMARY OBJECTIVE:

I. To evaluate the utility of early (i.e. during treatment) digital positron emission tomography (dPET) 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 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 local control 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.

IV. To generate preliminary data for future methodology or clinical trials.

OUTLINE:

Patients receive fludeoxyglucose F-18 via injection and undergo dPET over 20 minutes after standard of care computed tomography (CT) imaging (week -2), after receiving 20-26 Gy and 40-46 Gy of radiation (weeks 3 and 5), and 3 months after completion of treatment. Patients with concern for residual disease may receive an additional dPET 6 months after treatment.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient who will undergo definitive radiation with concurrent chemotherapy with cisplatin 40 mg/m^2 weekly (preferred) or high dose cisplatin 100 mg/m^2 for histologically confirmed locally advanced squamous cell carcinoma of the oropharynx
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 (archival or fresh)
Patients must provide their personal smoking history prior to registration
Patients must fall into one of the following stage (American Joint Committee on Cancer [AJCC] 8) and risk groups based on pre-treatment work-up and smoking history:
- Low risk classification:
  - p16 and/or HPV positive, T1-3, N1-2, M0 with =< 10 pack years smoking history OR
- Intermediate risk classification:
  - p16 and/or 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:
  - p16 and/or HPV negative, T4, N3, M0
  - p16 and/or HPV negative with > 10 pack year smoking history
Patients with no contraindications to PET imaging or cisplatin
No prior history of radiation therapy
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients with remaining teeth must undergo a dental evaluation prior to enrolment
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
Women of child-bearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until 60 days following the last study treatment

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