RECRUITING

De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers

Conditions

Oropharynx Cancer HPV tonsil base of tongue soft palate oropharyngeal cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn whether for intermediate-risk patients who have undergone Transoral Robotic Surgery for HPV/p16(+) oropharyngeal cancer and have minimal smoking history, whether these patients can be treated with a lower-than standard dose, with omission of the primary site in the oropharynx. The main questions it aims to answer are: Does radiotherapy site and dose-de-escalation lead to similar outcomes compared to historical data on tumor control in patients who are treated with standard radiation doses and treatment fields? Participants will: Undergo treatment with a lower than standard radiation dose (50Gy in 25 fractions, with either Intensity Modulated Radiation Therapy (IMRT) or proton beam therapy) and to a smaller than standard radiation field (to the neck only, excluding the original site of tumor in the oropharynx)

Official Title

A Phase II Study of Post-Resection Radiation Dose and Treatment Site De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer

Quick Facts

Study Start:2019-08-01

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06554158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients must be ≥ 18 years of age on the day of signing informed consent. * Patients must have a diagnosis of p16+ and/or HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus, tonsil, soft palate, vallecula, and/or posterior oropharyngeal wall). * pathologic stage T1-2 N1 M0 (AJCC 8th ed.) stage I or T3 N0-1 M0 stage II (AJCC 8th ed.) SCCA of the oropharynx, with ≤ 5 distinct nodes involved with tumor, ≤ 2mm ECE (extracapsular extension), ≥ 2mm surgical margins at primary site. * Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration. * neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration. * hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal. * current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history * start radiation within 8 weeks of resection (6 weeks preferable) * have undergone resection of the primary site with Transoral Surgery and neck dissection of at least the ipsilateral neck * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Ability to understand and willingness to sign a written informed consent.	* Perineural invasion at primary site * Lymphovascular space invasion at primary site * Level 4 nodal involvement (even if resected) * Retropharyngeal nodal involvement (even if resected) * any intact, unresected disease * nodal disease pathologically invading adjacent neck musculature * Patients treated via an invasive, non-oral approach to the primary site, including jaw-splitting mandibulotomy with resection or lateral pharyngotomy * Prior history of malignancy diagnosed within 2 years prior to registration, except for nonmelanomatous skin cancer that has completed treatment and the patient is deemed as being disease-free or Gleason 6 prostate cancer that is undergoing active surveillance. * Patient with extracapsular extension (ECE) who has not had a biopsy of an ipsilateral neck lymph node that demonstrated squamous cell carcinoma

Inclusion Criteria

Exclusion Criteria

* Patients must be ≥ 18 years of age on the day of signing informed consent.
* Patients must have a diagnosis of p16+ and/or HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus, tonsil, soft palate, vallecula, and/or posterior oropharyngeal wall).
* pathologic stage T1-2 N1 M0 (AJCC 8th ed.) stage I or T3 N0-1 M0 stage II (AJCC 8th ed.) SCCA of the oropharynx, with ≤ 5 distinct nodes involved with tumor, ≤ 2mm ECE (extracapsular extension), ≥ 2mm surgical margins at primary site.
* Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration.
* neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration.
* hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal.
* current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history
* start radiation within 8 weeks of resection (6 weeks preferable)
* have undergone resection of the primary site with Transoral Surgery and neck dissection of at least the ipsilateral neck
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability to understand and willingness to sign a written informed consent.

* Perineural invasion at primary site
* Lymphovascular space invasion at primary site
* Level 4 nodal involvement (even if resected)
* Retropharyngeal nodal involvement (even if resected)
* any intact, unresected disease
* nodal disease pathologically invading adjacent neck musculature
* Patients treated via an invasive, non-oral approach to the primary site, including jaw-splitting mandibulotomy with resection or lateral pharyngotomy
* Prior history of malignancy diagnosed within 2 years prior to registration, except for nonmelanomatous skin cancer that has completed treatment and the patient is deemed as being disease-free or Gleason 6 prostate cancer that is undergoing active surveillance.
* Patient with extracapsular extension (ECE) who has not had a biopsy of an ipsilateral neck lymph node that demonstrated squamous cell carcinoma

Contacts and Locations

Study Contact

Peter Ahn, MD

CONTACT

(202) 444-4036

Peter.H.Ahn@gunet.georgetown.edu

Study Locations (Sites)

Medstar Georgetown University Hospital

Washington, District of Columbia, 20007

United States

Collaborators and Investigators

Sponsor: Georgetown University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-01

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2019-08-01

Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

HPV
tonsil
base of tongue
soft palate
oropharyngeal cancer

Additional Relevant MeSH Terms

Oropharynx Cancer