Back to search results

Radiotherapy for Head and Neck Cancer After Surgery

This study is looking at two different ways to give radiation therapy (radiotherapy) to people with head and neck squamous cell carcinoma (HNSCC), a type of head and neck cancer. It compares accelerated radiotherapy (6 treatments per week, with two treatments on one day) to conventional radiotherapy (5 treatments per week, Monday through Friday). The goal is to see if accelerated radiotherapy is better at preventing the cancer from coming back in the treated area (locoregional recurrence-free survival) when radiation starts more than six weeks after surgery. You may be able to join if you have been diagnosed with HNSCC and are planning to have radiation therapy after surgery. The study aims to enroll 75 participants, and its current status is unclear.

Study design
This is an interventional study where 75 participants will be randomly assigned to receive either accelerated radiotherapy or conventional radiotherapy.
What's involved
Participants will receive either five fractions of radiation per week or six fractions of radiation per week, which includes twice-daily treatments on one day for the accelerated group.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track how long participants live without the cancer returning in the treated area for at least 2 years after radiotherapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06607406

Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC Greater Than 6 Weeks After Surgery

Recruiting
NAAges 18+InterventionalTreatment
Wake Forest University Health Sciences
~75 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Accelerated radiotherapyConventional radiotherapy

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Locoregional Recurrence-free Survival
Measured over 2 years post radiotherapy

Conditions

Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma HNSCC

Explore related trials

Head and Neck Squamous Cell CarcinomaHPV

Where it's being run

3 sites across 2 states
North Carolina2
Wisconsin1

Study leadership

  • Ryan Hughes, MD · PRINCIPAL_INVESTIGATOR · Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Who to contact

Ryan Hughes, MD
[email protected]
336-713-6575
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Pathologically confirmed head and neck squamous cell carcinoma of the oral cavity, oropharynx, larynx, hypopharynx, sinus, or lymph nodes of the neck of unknown primary.
Planned for curative intent postoperative radiotherapy based on pathologic risk factors.
Patients with non-HPV-mediated oropharyngeal squamous cell carcinoma or non-oropharyngeal squamous cell carcinoma must have at least one of the following: pathologic tumor classification pT3-4, multiple lymph nodes involved with cancer, perineural invasion, lymphovascular invasion, close margins (within 2 mm for oropharyngeal cancer status post transoral resection; within 5 mm for all others) or cleared margins (initially positive, subsequently cleared in an additional specimen), extranodal extension (any extent), or positive surgical margins.
Patients with HPV-mediated oropharyngeal squamous cell carcinoma must have at least one of the following pathologic risk factors: extranodal extension (any extent), positive surgical margins, or more than 4 lymph nodes involved with cancer.
Complete macroscopic surgical resection with curative intent for HNSCC with an anticipated interval between the primary surgical resection and initiation of postoperative radiotherapy greater than 42 days but less than or equal to 112 days from surgery. Note: the start date of the time to initiation of PORT is the first (primary) surgical resection. This does not include diagnostic procedures (e.g., biopsy, diagnostic tonsillectomy) or any subsequent surgical interventions for any reason (e.g., wound complications).
Age ≥ 18 years at the time of enrollment.
ECOG performance status of 0-1.
Ability to understand and the willingness to sign an IRB-approved informed consent document directly, in English or Spanish, and to complete study-related forms and activities.

Exclusion

Recurrent head and neck cancer that has recurred after prior courses of definitive RT or surgery followed by postoperative RT/CRT. Note that individuals who have been treated with surgery alone and are now recurrent are eligible.
Second primary head and neck cancer after initial treatment of a prior head and neck cancer.
History of prior radiotherapy to the head and neck region, such that any portion of the anticipated target volume overlaps with any region that was previously targeted.
Active malignancy other than the head and neck cancer to be treated with PORT (excluding non-melanoma skin cancer, in situ carcinoma of any site).
Metastatic disease from the head and neck cancer to be treated with PORT defined as distant organ involvement outside of the head and neck and/or non-regional lymph node involvement outside of the head and neck.
Time from primary surgical resection to anticipated initiation of PORT greater than 112 days.
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
Not a candidate for radiation therapy per treating clinician. For example, individuals who are pregnant or plan to become pregnant (due to the risks of the developing fetus) or any other contraindication to radiation therapy.

What this trial measures

  • Locoregional Recurrence-free Survival2 years post radiotherapy

    Time to locoregional recurrence, will be assessed on an intention to treat basis using a one-sided log rank test to compare hazard rates between groups. Kaplan-Meier survival curves will also be generated with locoregional failure or death as the event of interest and last clinical disease assessment as a right-censor.