Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03875716

Study of De_Intensified Postoperative Radiation Therapy for HPV Associated Oropharyngeal Squamous Cell Carcinoma

Led by Dana-Farber Cancer Institute · Updated on 2026-03-13

111

Participants Needed

1

Research Sites

554 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research study is studying lowering the standard dose of radiation and chemotherapy after surgery, to minimize the side effects and improve the quality of life.

CONDITIONS

Official Title

Study of De_Intensified Postoperative Radiation Therapy for HPV Associated Oropharyngeal Squamous Cell Carcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed squamous cell carcinoma of the tonsil or base of tongue (oropharynx) or unknown primary with p16-positive cervical lymph node metastases
  • HPV-associated tumor confirmed by positive p16 immunohistochemistry (>70%) or in situ hybridization or PCR-based methods
  • Eligible for curative-intent surgery with anticipated negative margins
  • Surgery performed at Brigham & Women's Hospital
  • Age 18 years or older
  • ECOG performance status 0-1 (Karnofsky ≥70%)
  • Normal organ and marrow function: leukocytes ≥3,000/mcL, absolute neutrophil count ≥1,000/mcL, platelets ≥100,000/mcL, total bilirubin within normal limits, AST/ALT ≤2.5× institutional upper limit, creatinine ≤1.5× institutional upper limit or creatinine clearance ≥60 mL/min/1.73 m2
  • ≤20 pack-years of cumulative cigarette smoking
  • Tumor clinical stage T0, T1, or T2
  • Nodal clinical stage N0 or N1
  • No distant metastases (M0)
  • Ability to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Prior history of head and neck cancer within 5 years
  • Prior head and neck radiation
  • Clinically fixed or matted lymph nodes
  • Uncontrolled illnesses such as active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness/social situations limiting study compliance
  • Pregnant women
  • Breastfeeding should be discontinued if enrolled due to treatment risks
  • Pregnancy status determined by serum pregnancy test

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02062

Actively Recruiting

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Research Team

D

Danielle N. Margalit, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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