Status:
UNKNOWN
Swallowing Outcomes and Circulating Tumor DNA in Patients With HPV Related Oropharyngeal Cancer Treated With Transoral Surgery and Reduced Intensity Adjuvant Therapy
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 (HP...
Detailed Description
PRIMARY OBJECTIVE: I. To measure swallowing function and disease specific quality of life of patients with oropharyngeal cancer treated with transoral surgery and reduced intensity adjuvant therapy. ...
Eligibility Criteria
Inclusion
- 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
- 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 the skin
- Patients with metastatic disease beyond the neck will be excluded
- Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
- Age \< 18 years
- Patients with human immunodeficiency virus (HIV) infection are not automatically excluded, but must meet the following criteria: CD4 count is \> 499/cu mm and their viral load is \< 50 copies/ml. Use of highly active antiretroviral therapy (HAART) is allowed
- Grade 3-4 electrolyte abnormalities (Common Terminology Criteria for Adverse Events \[CTCAE\], version \[v.\] 5)
- Serum calcium (ionized or adjusted for albumin) \< 7 mg/dl (1.75 mmol/L) or \> 12.5 mg/dl (\> 3.1 mmol/L) despite intervention to normalize levels
- Magnesium \< 0.9 mg/dl (\< 0.4 mmol/L) or \> 3 mg/dl (\> 1.23 mmol/L) despite intervention to normalize levels
- Potassium \< 3.0 mmol/L or \> 6 mmol/L despite intervention to normalize levels
- Sodium \< 130 mmol/L or \> 155 mmol/L despite intervention to normalize levels
- Women who are pregnant, due to the teratogenic effects of radiation therapy and chemotherapy on the unborn fetus. Women of childbearing age must agree to undergo a pregnancy test prior to therapy and to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 6 months after. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Tumor deemed unresectable with acceptable morbidity:
- Tumors \> 4 cm in size (T3 or higher)
- Tumors of the base of tongue \< 4 cm but with deep invasion of tongue musculature placing hypoglossal nerve or both lingual arteries at risk
- Significant extension into hypopharynx
- Extension into soft palate beyond 1/3 of the width
- Clinically extensive extranodal extension (ENE) e.g. radiologic evidence of invasion of carotid artery, gross extension into sternocleidomastoid muscle or deep neck muscles.
- Lymph nodes larger than 6 cm without clinical ENE will be allowed
Key Trial Info
Start Date :
July 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04920344
Start Date
July 19 2021
End Date
May 8 2025
Last Update
November 3 2023
Active Locations (3)
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1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
2
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick
New Brunswick, New Jersey, United States, 08903
3
Rutgers Cancer Institute of New Jersey at University Hospital
Newark, New Jersey, United States, 07103