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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03875716
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation therapy — RADIATION
    Radiation therapy

Study Details

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.

Key Dates

Start date
May 20, 2019
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
111 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Disease-free survival [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02062
Danielle N. Margalit, MD, MPH
[email protected]
617-632-3591
Danielle N. Margalit, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Dana Farber Cancer Institute· Boston, MA

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