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

The Ohio State University

Status

Withdrawn

Conditions

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Oropharyngeal Squamous Cell Carcinoma

Treatments

Procedure: Computed Tomography

Procedure: Positron Emission Tomography

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03611205

OSU-18030

NCI-2018-01322 (Registry Identifier)

P30CA016058 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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