Swallowing Outcomes and Circulating Tumor DNA in Patients With HPV Related Oropharyngeal Cancer Treated With Transoral Surgery and Reduced Intensity Adjuvant Therapy
4 other identifiers
interventional
15
1 country
3
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 (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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2021
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2021
CompletedFirst Posted
Study publicly available on registry
June 9, 2021
CompletedStudy Start
First participant enrolled
July 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2025
CompletedNovember 3, 2023
November 1, 2023
3.8 years
June 2, 2021
November 1, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
MD Anderson Dysphagia Index (MDADI)
MDADI is a 20 item quality of life instrument specifically focusing on swallowing aspects. It was originally designed for head and neck cancer patients and has been widely used and validated in this population. The total score ranges from 20 to 100 with the higher score indicating higher level of function.
At baseline.
MD Anderson Dysphagia Index (MDADI)
MDADI is a 20 item quality of life instrument specifically focusing on swallowing aspects. It was originally designed for head and neck cancer patients and has been widely used and validated in this population. The total score ranges from 20 to 100 with the higher score indicating higher level of function.
At 24 weeks post completion of therapy.
MD Anderson Dysphagia Index (MDADI)
MDADI is a 20 item quality of life instrument specifically focusing on swallowing aspects. It was originally designed for head and neck cancer patients and has been widely used and validated in this population. The total score ranges from 20 to 100 with the higher score indicating higher level of function.
At 1 year post completion of therapy.
Secondary Outcomes (9)
Locoregional control.
At 3 years post completion of therapy
Disease free survival.
At 3 years post completion of therapy
Progression free survival.
At 3 years post completion of therapy
Overall survival.
At 3 years post completion of therapy
University of Washington Quality of Life Questionnaire
At baseline, 24 weeks and 1 year post completion of therapy
- +4 more secondary outcomes
Study Arms (3)
GROUP I - Low Risk Recurrence (transoral surgery, clinical observation))
ACTIVE COMPARATORAfter standard of care transoral surgery, patients whose small tumor was removed completely and have only one lymph node involved will undergo clinical observation.
GROUP II - Medium Risk Recurrence (transoral surgery, EBRT 50Gy)
EXPERIMENTALPatients whose tumor was removed completely but has certain features that make it more likely to come back such as growth around the nerves or into the vessels, or has more than one lymph nodes involved, will undergo external body radiation therapy (EBRT) RT 50Gy for 5 weeks in the absence of disease progression or unacceptable toxicity.
GROUP III - High Risk Recurrence (transoral surgery, EBRT 60Gy, cisplatin 30 mg/m2)
EXPERIMENTALPatients whose tumor has a "positive margin", which means the tumor could not be removed with healthy tissue around it or tumor grows significantly outside the lymph node will undergo EBRT RT 60 Gy for 6 weeks and receive cisplatin intravenously (IV) weekly 30mg/m2 for 6 weeks in the absence of disease progression or unacceptable toxicity.
Interventions
Patients will undergo transoral surgery
Patients in Group II and Group III will undergo External Beam Radiation Therapy (EBRT) RT following transoral surgery.
Patients in Group III will receive cisplatin, 30 mg/m2, administered intravenously weekly per for 6 weeks.
Incisional biopsy of the primary tumor site will be required to confirm p16/HPV status of the tumor
Assess ctDNA levels at baseline, 2 weeks, 4 weeks, 10 weeks, 24 weeks and 1 year after the surgery.
MDADI is a 20 item quality of life questionnaire specifically focusing on swallowing aspects. It was originally designed for head and neck cancer patients. The total score ranges from 20 to 100 with the higher score indicating higher level of function.
University of Washington Questionnaire is a 15 item quality of life instrument specifically designed for head and neck cancer patients.
A generic quality of life and cost utility instrument widely used and validated for multiple disease settings, including head and neck cancer.
The videofluoroscopic modified barium swallow (MBS) study is the gold standard for for the evaluation of dysphagia, and specifically, airway protective mechanisms. The penetration/aspiration (PEN/ASP) scale is a routinely used eight-point scale designed to describe the depth of bolus penetration into the airway and the patient response to the penetration or aspiration.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick
New Brunswick, New Jersey, 08903, United States
Rutgers Cancer Institute of New Jersey at University Hospital
Newark, New Jersey, 07103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matin Imanguli, MD, DDS
Rutgers Cancer Institute of New Jersey
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor. Chief of the Division of Head and Neck Surgical Oncology
Study Record Dates
First Submitted
June 2, 2021
First Posted
June 9, 2021
Study Start
July 19, 2021
Primary Completion
May 8, 2025
Study Completion
May 8, 2025
Last Updated
November 3, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share