Study of Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration in HPV+ Head and Neck Cancer of Unknown Primaries

NCT04489212 | Completed DMC

• 2 other identifiers: MC1974NCI-2020-05152
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical trial evaluates the clinical outcome of mucosal sparing adjuvant radiotherapy after surgical exploration in HPV+ head and neck cancer of unknown primaries. The purpose of this research is to assess if radiation treatment to the neck only for tumors with unclear original locations after careful surgical evaluation will lead to historical rates of disease control while reducing side effects and toxicity from treatment.

Conditions

Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Head and Neck Carcinoma of Unknown Primary; Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (1)

• Primary local recurrence

  Will be estimated by counting up the number of patients with an occult primary tumor within the pharyngeal axis or nodal recurrence in untreated neck and dividing by the total number of eligible patients.

  At 2 years

Secondary Outcomes (7)

• Incidence of acute grade 3 or higher functional mucosal adverse events

  Up to 1 month post radiation therapy (XRT)

• Overall survival (OS)

  From registration to death due to any cause, assessed up to 5 years

• Recurrence-free survival (RFS)

  From registration to the first of either disease recurrence, delayed lymph node metastasis in an untreated neck (contralateral), development of distant metastatic disease, or death, assessed up to 5 years

• Distant metastasis rates

  Up to 2 years

• Change in swallowing function

  Up to 5 years

Study Arms (1)

Treatment (follow-up, observation)

EXPERIMENTAL

Patients who have recurrence or progression during treatment or observation have medical charts are reviewed every 6 months for 5 years. Patients who complete adjuvant treatment are followed for observation 3 days after radiation therapy, 1 month after radiation therapy, every 3 months after radiation therapy for 2 years, every 6 months for 1 year, and then annually for 2 years.

Other: Medical Chart Review; Other: Patient Observation; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Medical Chart Review OTHER

Review of medical chart

Also known as: Chart Review

Treatment (follow-up, observation)

Patient Observation OTHER

Undergo observation

Also known as: Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting

Treatment (follow-up, observation)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (follow-up, observation)

Questionnaire Administration OTHER

Ancillary studies

Treatment (follow-up, observation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients meet criteria for intensity-modulated proton therapy (IMPT) treatment for oropharyngeal cancer
• If IMPT is declined by patient's insurance, they can be treated with standard of care IMRT using the same applicable standard of care procedures outlined in the procedures manual
• Meet criteria for adjuvant chemotherapy (if applicable)
• Histological confirmation of human papillomavirus (HPV)+ squamous cell carcinoma as defined by neck node pathology. HPV positivity will be defined as positive staining for p16 and HPV deoxyribonucleic acid (DNA) in situ hybridization (ISH). (If discordant, ribonucleic acid \[RNA\] ISH will be run for confirmatory testing)
• Clinical stage T0 N1-N3 and confirmed pathologic stage T0 N1-N2 M0 (American Joint Committee on Cancer \[AJCC\] 8th edition) with one of the following risk factors:
• Lymph node \>= 3 cm
• \>= 2 positive lymph nodes
• Presence of extracapsular extension
• \> 1 nodal level involved
• Absence of distant metastases on standard diagnostic workup, prior to registration (chest computed tomography \[CT\], chest x-ray \[CXR\], or positron emission tomography \[PET\]/CT)
• Able to undergo pre-operative Q-clear series PET/CT head/neck for diagnostic workup of occult primary and nodal disease
• Able to undergo transoral surgery and neck dissection by their ears, nose, and throat (ENT) oncologist
• Surgical exploration/sampling of all mucosal sites including ipsilateral wide field tonsillectomy and base of tongue resection. Additional biopsies or surgical excision at the surgeon's discretion. Any radiographic or clinically suspicious areas should be biopsied or removed. Bilateral neck dissection for high risk patients. Ipsilateral dissection only, for patients with contralateral cN0 necks and negative preoperative imaging
• Final pathologic evaluation demonstrating all benign samplings without discernible primary
• Documented smoking history

You may not qualify if:

• Any patient with positive retropharyngeal nodes on imaging
• Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Other active malignancy =\< 5 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer, breast cancer, prostate cancer, well-differentiated thyroid cancer, carcinoma-in-situ of the cervix. NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
• Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• History of connective tissue disorders such as scleroderma, rheumatoid arthritis, lupus, or Sjogren's disease
• Prior history of radiation therapy to the affected site

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Interventions

Watchful Waiting; Observation

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Methods; Investigative Techniques

Study Officials

• Daniel J. Ma, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 28, 2020
• Study Start: October 6, 2020
• Primary Completion: January 29, 2024
• Study Completion: January 29, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

US (2)