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 range18 Years
SexALL
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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 …
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