Swallowing Outcomes and Circulating Tumor DNA in Patients With HPV Related Oropharyngeal Cancer T… (NCT04920344) | Clinical Trial Compass
UnknownPhase 2
Swallowing Outcomes and Circulating Tumor DNA in Patients With HPV Related Oropharyngeal Cancer Treated With Transoral Surgery and Reduced Intensity Adjuvant Therapy
United States15 participantsStarted 2021-07-19
Plain-language summary
This is a non-randomized, open-label phase II clinical trial that studies the effect of reduced dose radiation therapy and chemotherapy after surgery in treating patients with human papillomavirus (HPV) caused throat cancer. Giving reduced dose radiation therapy and chemotherapy after surgery may improve quality of life compared with standard of care primary chemoradiation approach without compromising survival.
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:
* Histologically proven squamous cell carcinoma of the oropharynx
* Clinical stage T1-2, N0-N3, M0 by American Joint Committee on Cancer (AJCC) 8 criteria
* Must have tumors deemed surgically resectable with acceptable morbidity
* Estimated life expectancy of at least 12 weeks
* Must give informed consent
* Must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 3
* Must have detectable circulating HPV DNA levels
* Platelets \>= 100,000/ul
* Absolute neutrophil count (ANC) \>= 1,500/ul
* Hemoglobin \> 8 g/dl (use of transfusion to achieve this is acceptable)
* Total bilirubin \< 2 X institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \< 3 X institutional ULN
* Serum creatinine \< 2 x institutional ULN or creatinine clearance \> 50 ml/min as determined by 24 hour collection or estimated by Cockcroft-Gault formula
* Negative pregnancy test, if applicable
Exclusion Criteria:
* Patients may not have received previous therapy for their head and neck squamous cell carcinoma (SCC), including chemotherapy, radiation therapy, or surgery beyond biopsy
* Second primary malignancy. Exceptions are:
* Patient had a second primary malignancy but has been treated and disease free for at least 3 years
* In situ carcinoma (e.g. in situ carcinoma of the cervix)
* Non-melanomatous carcinoma of …
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
1
MD Anderson Dysphagia Index (MDADI)
Timeframe: At baseline.
2
MD Anderson Dysphagia Index (MDADI)
Timeframe: At 24 weeks post completion of therapy.
3
MD Anderson Dysphagia Index (MDADI)
Timeframe: At 1 year post completion of therapy.
Trial details
NCT IDNCT04920344
SponsorRutgers, The State University of New Jersey