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

NCT06554158 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00000196
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Oropharynx Cancer

Keywords

HPV; tonsil; base of tongue; soft palate; oropharyngeal cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  2 year progression free survival, as determined by standard of care physical examination and standard of care surveillance imaging.

  2 year

Secondary Outcomes (6)

• Quality of Life (QOL)

  2 year

• Local Control Rate

  2 year

• Regional Control Rate

  2 year

• Distant Metastasis-Free Survival (DMFS)

  2 year

• Overall Survival (OS)

  2 year

Study Arms (1)

Radiation dose: 50Gy

EXPERIMENTAL

50Gy in 25 fractions to the neck at risk for tumor recurrence, excluding the primary site

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

De-escalation of Adjuvant Radiotherapy

Radiation dose: 50Gy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MedStar Georgetown University Hospital: collaborator
• Georgetown University: lead

Study Sites (1)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Peter Ahn, MD

CONTACT

(202) 444-4036; Peter.H.Ahn@gunet.georgetown.edu

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: August 13, 2024
• First Posted: August 15, 2024
• Study Start: August 1, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)