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Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Phase 2NCT04920344

Swallowing Outcomes and Circulating Tumor DNA in Patients With HPV Related Oropharyngeal Cancer Treated With Transoral Surgery and Reduced Intensity Adjuvant Therapy

A Phase 2 study testing Transoral Surgery, External Beam Radiation Therapy and Cisplatin in people with Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by Rutgers, The State University of New Jersey at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Transoral Surgery, External Beam Radiation Therapy and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
3 sitesUnited States
Study dates
19 May 2021to Sep 2026
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick

    New Brunswick, New Jersey, 08903

  • Rutgers Cancer Institute of New Jersey at University Hospital

    Newark, New Jersey, 07103

Other trials in United States

About this study

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Transoral Surgery, External Beam Radiation Therapy, Cisplatin, Incisional Tumor Biopsy, Circulating tumor deoxyribonucleic acid (ctDNA) levels assessment
Medical subject headings
Oropharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transoral SurgeryProcedure or surgery

    Also called Therapeutic Conventional Surgery

    Patients will undergo transoral surgery

  • External Beam Radiation TherapyRadiation

    Also called EBRT

    Patients in Group II and Group III will undergo External Beam Radiation Therapy (EBRT) RT following transoral surgery.

  • CisplatinDrug

    Also called Cisplatin Chemotherapy

    Patients in Group III will receive cisplatin, 30 mg/m2, administered intravenously weekly per for 6 weeks.

  • Incisional Tumor BiopsyProcedure or surgery

    Incisional biopsy of the primary tumor site will be required to confirm p16/HPV status of the tumor

  • Circulating tumor deoxyribonucleic acid (ctDNA) levels assessmentOther

    Also called Circulating 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 IndexOther

    Also called MDADI

    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 QuestionnaireOther

    Also called UW QOL 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 questionnaireOther

    Also called EQ-5D-5L

    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 scaleDiagnostic test

    Also called MBS with PEN/ASP 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.

Study groups in NCT04920344
Study groupRoleWhat they receive
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.
Receives: Procedure: Transoral Surgery; Procedure: Incisional Tumor Biopsy; Other: Circulating tumor deoxyribonucleic acid (ctDNA) levels assessment; Other: MD Anderson Dysphagia Index; Other: University of Washington Quality of Life Questionnaire; Other: Euro-QOL 5 dimension scale questionnaire; Diagnostic Test: Modified barium swallow (MBS) evaluation with aspiration-penetration scale
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.
Receives: Procedure: Transoral Surgery; Radiation: External Beam Radiation Therapy; Procedure: Incisional Tumor Biopsy; Other: Circulating tumor deoxyribonucleic acid (ctDNA) levels assessment; Other: MD Anderson Dysphagia Index; Other: University of Washington Quality of Life Questionnaire; Other: Euro-QOL 5 dimension scale questionnaire; Diagnostic Test: Modified barium swallow (MBS) evaluation with aspiration-penetration scale
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.
Receives: Procedure: Transoral Surgery; Radiation: External Beam Radiation Therapy; Drug: Cisplatin; Procedure: Incisional Tumor Biopsy; Other: Circulating tumor deoxyribonucleic acid (ctDNA) levels assessment; Other: MD Anderson Dysphagia Index; Other: University of Washington Quality of Life Questionnaire; Other: Euro-QOL 5 dimension scale questionnaire; Diagnostic Test: Modified barium swallow (MBS) evaluation with aspiration-penetration scale

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline.

  2. 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.

    Measured: At 24 weeks post completion of therapy.

  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.

    Measured: At 1 year post completion of therapy.

Secondary outcomes (9)

  1. Locoregional control.

    Will be assessed using survival analysis (e.g., Kaplan-Meier method and Cox proportional hazards model).

    Measured: At 3 years post completion of therapy

  2. Disease free survival.

    Will be assessed using survival analysis (e.g., Kaplan-Meier method and Cox proportional hazards model).

    Measured: At 3 years post completion of therapy

  3. Progression free survival.

    Will be assessed using survival analysis (e.g., Kaplan-Meier method and Cox proportional hazards model).

    Measured: At 3 years post completion of therapy

  4. Overall survival.

    Will be assessed using survival analysis (e.g., Kaplan-Meier method and Cox proportional hazards model).

    Measured: At 3 years post completion of therapy

  5. 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. Scoring is scaled to so that a score of 0 represents the worst possible response, and a score of 100 represents the best possible response. The higher the score - the better the outcome.

    Measured: At baseline, 24 weeks and 1 year post completion of therapy

  6. European Quality of Life Five Dimension Five Level Scale Questionnaire scores

    Euro-QOL 5 dimension scale is a generic quality of life and cost utility instrument widely used and validated for multiple disease settings, including head and neck cancer.

    Euro-QOL 5 dimension scale is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).

    Measured: At baseline, 24 weeks, and 1 year post completion of therapy

  7. Rate of gastrostomy tube dependence

    Percentage of patients requiring a gastrostomy tube after completion of therapy will be analyzed using generalized linear model (GLM) analysis.

    Measured: At baseline, 24 weeks, and 1 year post completion of therapy

  8. Penetration-Aspiration Score on Modified Barium Swallow examination

    Objective swallowing function assessment using modified barium swallow (MBS) evaluation with aspiration-penetration scale.

    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. The higher the score, the worse is the outcome.

    Measured: Baseline and 1 year post completion of therapy

  9. Correlation of circulating tumor deoxyribonucleic acid (ctDNA) levels with known adverse pathological features

    Correlation of ctDNA levels at baseline with known adverse pathological features such as, number of involved lymph nodes, extranodal extension and positive margins. Will be analyzed using GLM analysis.

    Measured: At baseline and at 4 weeks post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study start19 May 2021
  3. Primary completion30 May 2026
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04920344
Sponsor's protocol ID
032008
Other IDs
Pro2020002824, NCI-2021-03006, P30CA072720
Status last verified
Aug 2026
First submitted
2 Jun 2021
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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