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

NCT03875716 | Recruiting DMC FDA Device

• 1 other identifier: 19-009
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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

Keywords

radiation de-intensification

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Survival without any signs or symptoms of cancer after the treatment ends.

  2 years

Secondary Outcomes (6)

• Overall Survival

  2 years

• Toxicity Rate

  2 years

• Quality Of Life Questionnaire

  2 Years

• Symptom burden:

  2 years

• Dysphagia

  2 Years

Study Arms (3)

Low Risk

EXPERIMENTAL

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

Radiation: Radiation therapy

Intermediate Risk

EXPERIMENTAL

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

Radiation: Radiation therapy

High Risk

EXPERIMENTAL

Postoperative radiation (60Gy) without chemotherapy * Pathologic T0-4N0-2 and any one of the following features: -\>1mm extranodal extension * Microscopic positive margins

Radiation: Radiation therapy

Interventions

Radiation therapy RADIATION

Radiation therapy

High Risk; Intermediate Risk; Low Risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02062, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Danielle N. Margalit, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle N. Margalit, MD, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 15, 2019
• Study Start: May 20, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• Access Criteria: BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)