Recruiting

De_Intensified Radiation

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT03875716

Conditions

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation therapy

Study Details

Brief summary:

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

Head and Neck Cancer

Study ID

NCT03875716

Start date

May 20, 2019

Status verified date

Mar, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 as defined 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 or older years.
  • ECOG performance status 0-1 (Karnofsky ≥70%, see Appendix A)
  • Normal organ and marrow function as defined below:

  • leukocytes ≥3,000/mcL
  • absolute neutrophil count ≥1,000/mcL
  • platelets ≥100,000/mcL
  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
  • creatinine ≤ 1.5 times the institutional upper limit of normal OR
  • creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
  • Patients with ≤20 pack-years of cumulative cigarette smoking. Pack-years are calculated by multiplying the number of years smoked with the pack of cigarettes smoked per day. One pack is considered to contain 20 cigarettes.
  • Tumor clinical stage (AJCC 8th edition): T0 or T1 or T2
  • Nodal clinical stage (AJCC 8th edition): N0 or N1
  • No distant metastases. Clinical M-stage must be M0 (AJCC 8th edition).
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Prior history of head and neck cancer within 5 years.
  • Prior head and neck radiation
  • Clinically fixed or matted nodes
  • 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. Note: that HIV positive patients will be eligible.
  • Pregnant women are excluded from this study because of the teratogenic risks of radiation exposure to the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with radiation therapy and supportive care medications required for symptomatic management of head and neck cancer side effects as well as general anesthesia required for oncologic head and neck surgery, breastfeeding should be discontinued if the mother is enrolled in the study. Pregnancy status will be determined by a serum pregnancy test.

Study Design

Enrollment

111 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low Risk

Observation without adjuvant therapy

  • Pathologic T0-2, N0-1
  • Minimum of 15 lymph nodes retrieved on neck dissection per dissected side of the neck
  • Single positive lymph node up to 3cm
  • No extranodal extension
  • Clear margins
  • Undetectable postoperative circulating tumor HPV DNA

experimental: Intermediate Risk

Reduced-dose radiation (46Gy)

  • Pathologic T0-2N0-2 and any one of the following features:
  • 2 or more positive lymph nodes
  • single node >3cm
  • <15 lymph nodes retrieved on neck dissection for each side of the neck
  • Positive lymph nodes in level IB, IV, or V

-≤1mm extranodal extension
  • Positive lymph node(s) contralateral to the primary tumor
  • Close margins
  • Detectable postoperative circulating tumor HPV DNA

experimental: High Risk

Postoperative radiation (60Gy) without chemotherapy

  • Pathologic T0-4N0-2 and any one of the following features:

->1mm extranodal extension
  • Microscopic positive margins

Interventions

Radiation therapy

Radiation therapy

Primary outcome measure

  • Disease-free survival [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Danielle N. Margalit, MD, MPH

617-632-3591danielle_margalit@dfci.harvard.edu

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02062

Contacts

Danielle N. Margalit, MD, MPH

617-632-3591danielle_margalit@dfci.harvard.edu

Principal Investigator:

Danielle N. Margalit, MD, MPH

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

  • radiation de-intensification

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-03-13.