WithdrawnNot Applicable

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

Stopped: PI decision

United States0Started 2020-10-09

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 rema…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to 2 years

Trial details

NCT IDNCT04140513

SponsorOhio State University Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-01

View on ClinicalTrials.gov More Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 trials