Swallowing Outcomes and Circulating Tumor DNA in Patients With HPV Related Oropharyngeal Cancer Treated With Transoral Surgery and Reduced Intensity Adjuvant Therapy
NCT ID: NCT04920344
Last Updated: 2023-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
15 participants
INTERVENTIONAL
2021-07-19
2025-05-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer
NCT01898494
Using CircuLating Tumor DNA to Risk Adapt Post-Operative Therapy for HPV-associated Oropharyngeal Cancer
NCT06445114
De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers
NCT06554158
Trial of De-Intensified Post-operative Chemoradiation Following Robotic Surgery for HPV-positive Oropharyngeal Cancer
NCT04502407
A Study of Reduced Radiation Therapy and Standard-of-Care Chemotherapy in People With HPV-Positive Throat Cancer
NCT05491512
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
SECONDARY OBJECTIVES:
I. To examine kinetics of circulating tumor deoxyribonucleic acid (DNA) in patients treated with transoral surgery.
II. To estimate local control, progression free and overall survival using transoral surgery and reduced intensity adjuvant therapy.
OUTLINE: Based on pathologic findings after standard of care transoral surgery, patients are assigned to 1 of 3 groups.
GROUP I (LOW RISK): Patients whose small tumor was removed completely and have only one lymph node involved will undergo clinical observation.
GROUP II (MEDIUM RISK): Patients 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) for 5 weeks in the absence of disease progression or unacceptable toxicity.
GROUP III (HIGH RISK): Patients 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 for 6 weeks and receive cisplatin intravenously (IV) weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 3 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GROUP I - Low Risk Recurrence (transoral surgery, clinical observation))
After standard of care transoral surgery, patients whose small tumor was removed completely and have only one lymph node involved will undergo clinical observation.
Transoral Surgery
Patients will undergo transoral surgery
Incisional Tumor Biopsy
Incisional biopsy of the primary tumor site will be required to confirm p16/HPV status of the tumor
Circulating tumor deoxyribonucleic acid (ctDNA) levels assessment
Assess ctDNA levels at baseline, 2 weeks, 4 weeks, 10 weeks, 24 weeks and 1 year after the surgery.
MD Anderson Dysphagia Index
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 Quality of Life Questionnaire
University of Washington Questionnaire is a 15 item quality of life instrument specifically designed for head and neck cancer patients.
Euro-QOL 5 dimension scale questionnaire
A generic quality of life and cost utility instrument widely used and validated for multiple disease settings, including head and neck cancer.
Modified barium swallow (MBS) evaluation with aspiration-penetration scale
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.
GROUP II - Medium Risk Recurrence (transoral surgery, EBRT 50Gy)
Patients 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.
Transoral Surgery
Patients will undergo transoral surgery
External Beam Radiation Therapy
Patients in Group II and Group III will undergo External Beam Radiation Therapy (EBRT) RT following transoral surgery.
Incisional Tumor Biopsy
Incisional biopsy of the primary tumor site will be required to confirm p16/HPV status of the tumor
Circulating tumor deoxyribonucleic acid (ctDNA) levels assessment
Assess ctDNA levels at baseline, 2 weeks, 4 weeks, 10 weeks, 24 weeks and 1 year after the surgery.
MD Anderson Dysphagia Index
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 Quality of Life Questionnaire
University of Washington Questionnaire is a 15 item quality of life instrument specifically designed for head and neck cancer patients.
Euro-QOL 5 dimension scale questionnaire
A generic quality of life and cost utility instrument widely used and validated for multiple disease settings, including head and neck cancer.
Modified barium swallow (MBS) evaluation with aspiration-penetration scale
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.
GROUP III - High Risk Recurrence (transoral surgery, EBRT 60Gy, cisplatin 30 mg/m2)
Patients 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.
Transoral Surgery
Patients will undergo transoral surgery
External Beam Radiation Therapy
Patients in Group II and Group III will undergo External Beam Radiation Therapy (EBRT) RT following transoral surgery.
Cisplatin
Patients in Group III will receive cisplatin, 30 mg/m2, administered intravenously weekly per for 6 weeks.
Incisional Tumor Biopsy
Incisional biopsy of the primary tumor site will be required to confirm p16/HPV status of the tumor
Circulating tumor deoxyribonucleic acid (ctDNA) levels assessment
Assess ctDNA levels at baseline, 2 weeks, 4 weeks, 10 weeks, 24 weeks and 1 year after the surgery.
MD Anderson Dysphagia Index
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 Quality of Life Questionnaire
University of Washington Questionnaire is a 15 item quality of life instrument specifically designed for head and neck cancer patients.
Euro-QOL 5 dimension scale questionnaire
A generic quality of life and cost utility instrument widely used and validated for multiple disease settings, including head and neck cancer.
Modified barium swallow (MBS) evaluation with aspiration-penetration scale
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Transoral Surgery
Patients will undergo transoral surgery
External Beam Radiation Therapy
Patients in Group II and Group III will undergo External Beam Radiation Therapy (EBRT) RT following transoral surgery.
Cisplatin
Patients in Group III will receive cisplatin, 30 mg/m2, administered intravenously weekly per for 6 weeks.
Incisional Tumor Biopsy
Incisional biopsy of the primary tumor site will be required to confirm p16/HPV status of the tumor
Circulating tumor deoxyribonucleic acid (ctDNA) levels assessment
Assess ctDNA levels at baseline, 2 weeks, 4 weeks, 10 weeks, 24 weeks and 1 year after the surgery.
MD Anderson Dysphagia Index
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 Quality of Life Questionnaire
University of Washington Questionnaire is a 15 item quality of life instrument specifically designed for head and neck cancer patients.
Euro-QOL 5 dimension scale questionnaire
A generic quality of life and cost utility instrument widely used and validated for multiple disease settings, including head and neck cancer.
Modified barium swallow (MBS) evaluation with aspiration-penetration scale
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Rutgers, The State University of New Jersey
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Matin Imanguli, MD, DDS
Assistant Professor. Chief of the Division of Head and Neck Surgical Oncology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matin Imanguli, MD, DDS
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick
New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey at University Hospital
Newark, New Jersey, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro2020002824
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2021-03006
Identifier Type: REGISTRY
Identifier Source: secondary_id
032008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.