Head and Neck CancerNCT06607406
Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC Greater Than 6 Weeks After Surgery
A study testing Accelerated radiotherapy and Conventional radiotherapy in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma HNSCC, run by Wake Forest University Health Sciences at 3 sites in United States.
Trial summary
The goal of this clinical trial is to determine whether accelerated radiotherapy (involving 6 treatments per week) is better than standard radiotherapy (involving 5 treatments per week) at treating cancer of the head and neck when initiated more than 6 weeks after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma HNSCC
- What is being tested?
- Accelerated radiotherapy and Conventional radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Jan 2025to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Matthew Ward, MD, (980)442-1100, matthew.ward@atriumhealth.org
- Recruiting
Advocate Aurora Radiation Oncology
Milwaukee, Wisconsin, 53215
Pamela Vanderwall, MD, 414-649-6420, Pamela.Vanderwall@advocatehealth.org
- Recruiting
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Ryan Hughes, MD, (336) 713-6575, ryhughes@wakehealth.edu
About this study
Official title: A Randomized Trial of Accelerated Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC (Head and Neck Squamous Cell Carcinoma) Initiating Radiotherapy Greater Than 6 Weeks After Surgery (PORTRush)
The goal of this clinical trial is to determine whether accelerated radiotherapy (involving 6 treatments per week) is better than standard radiotherapy (involving 5 treatments per week) at treating cancer of the head and neck when initiated more than 6 weeks after surgery.
Read the detailed description
This study is a randomized trial designed to determine the effect of Accelerated Fractionation (AF) versus Conventional Fractionation (CF) PORT on locoregional recurrence-free survival, progression-free survival, overall survival, toxicity, and treatment package time in participants with resected intermediate and high-risk Head and Neck Squamous Cell Carcinoma (HNSCC) planned to start Post Operative Radiotherapy (PORT) greater than six weeks after surgery. Eligible participants in both cohorts will be randomized 1:1 to receive five fractions per week of standard conventional fractionation radiotherapy or six fractions per week of accelerated fractionation radiotherapy. If randomized to the standard conventional fractionation group, participants will be treated with five fractions of radiation per week, received daily. If randomized to the accelerated fractionation group, participants will be treated with 6 fractions of radiotherapy per week, received daily and twice daily treatments on one day of the week.
- Being tested
- Accelerated radiotherapy, Conventional radiotherapy
- Keywords
- Radiotherapy, Accelerated radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated radiotherapyRadiation
6 fractions per week, BID fractions one day per week
Conventional radiotherapyRadiation
5 fractions per week, daily M-F
| Study group | Role | What they receive |
|---|---|---|
| Conventional fractionation (5 Fractions) | Active comparator | 5 fractions per week, daily treatment Monday-Friday; dosage at the discretion of the treating radiation oncologist per standard of care Receives: Radiation: Conventional radiotherapy |
| Accelerated fractionation (6 Fractions) | Experimental | 6 fractions per week, daily treatment plus twice daily treatment for 1 day Monday-Friday; dosage at the discretion of the treating radiation oncologist per standard of care Receives: Radiation: Accelerated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional Recurrence-free Survival
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.
Measured: 2 years post radiotherapy
Secondary outcomes (9)
Progression free survival (PFS)
Progression-free survival will be calculated from the time of randomization to disease recurrence or death from any cause as the event and last follow-up as a right-censor. It will be compared between treatment arms.
Measured: up to 5 years
Overall survival (OS)
Overall survival will be calculated from the time of randomization to death from any cause, with last follow-up as a right-censor.
Measured: up to 5 years
Acute and late toxicities
Acute and late toxicities between each treatment arm will be measured by evaluating adverse events (AEs) by grade in each treatment arm. Using the Chi-square test (or Fisher's exact test if cell frequencies <5) and a significance level of 0.05, comparisons will be made of the following outcomes between treatment arms: 1) the number of participants with at least one AE of grade 3 or higher, 2) the number of participants with grade 1 or higher toxicity, and 3) the number of patients with grade 3 or higher toxicity. Each of these analyses will result in the construction of 2x2 tables thus the use of the Chi-Square (or Fisher's exact test) will be appropriate. These analyses will be completed for both acute (between RT start and 90 days after RT) and late (more than 90 days after RT completion) toxicities.
Measured: up to 24 months post radiotherapy
Patient Report Outcomes (PRO) - PRO-CTCAE
PRO-CTCAE measure of toxicity will be assessed by describing the counts and frequencies for the worst score observed in each participant in the whole cohort and by treatment arm. Using the Chi-square test (or Fisher's exact test if cell frequencies <5) and a significance level of 0.05, a comparison will occur of the following outcomes between treatment arms: 1) the number of patients with at least one PRO-CTCAE score of grade 1 or higher, and 2) the number of patients with at least one PRO-CTCAE score of grade 3 or higher. These comparisons 1 and 2 will be completed for both acute (between RT start and 90 days after RT) and late (more than 90 days after RT completion) toxicities. The analysis of change in PRO-CTCAE score over time will also be performed using a likelihood-based Generalized Linear Mixed Model (GLMM) approach.
Measured: at baseline, end radiotherapy (RT), 3, 6, 12, and 24-months post RT
Patient Reported Outcomes (PRO) - MDASI-HN
The MDASI-HN is a 28-item measure with three subscales: the 13 core MDASI items, 9 head and neck cancer-specific items, and 6 items specific to interference in daily life by the patient's symptoms. The change from baseline at each time point will be summarized using mean and standard deviation at end RT, 3, 6, 12, and 24-months post RT.
Measured: at End of Radiotherapy (RT), 3, 6, 12, and 24-months post RT
Nutritional Toxicity
Nutritional toxicity will be measured by comparing the rates of reactive gastrostomy tube placement using a Fisher's exact test. For patients in whom a feeding tube is placed, the duration of tube will be defined as the time from tube placement to removal or last follow-up with a tube (right-censor) and will be estimated using the Kaplan-Meier method and compared between groups using the log-rank statistics.
Measured: up to 24 months post Radiotherapy
Time to initiation of Postoperative Radiotherapy (PORT)
Time to initiation of PORT will be calculated as the number of days from date of primary curative resection (surgery date = day 0) to initiation of RT. This value will be compared between groups using a 2-sample t-test to see if there is a significant difference between groups on this covariate.
Measured: up to 16 weeks
Treatment package time
The treatment package time will be calculated as the number of days from the primary surgical resection to the end of PORT (the last RT treatment for participants who complete therapy; for participants who do not complete the prescribed course of RT, this metric is moot) and compared between groups using a 2-sample T-test. The proportion of patients with treatment package time less than 100 days will be determined and compared between groups using the Chi-square test (or Fisher's exact test if cell frequencies <5).
Measured: from surgical resection to end of PORT - up to approx. 165 days
Demographic characteristics of eligible participants
The characteristics (age, gender assigned at birth, race, ethnicity) of potentially eligible participants will be described using count and frequency for categorical variables and mean (standard deviation) and median (range) for continuous variables. These factors will be compared between groups who do and do not enroll on study using the Chi-square tests for categorical and 2-sample t-tests for continuous measures. For participants who choose not to enroll, the reasons and rationale provided to support that decision will be described using count and frequency.
Measured: Prior to Radiotherapy (Pre-screening and baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start21 Jan 2025
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Hughes, MD, Principal investigator, Atrium Health Wake Forest Baptist Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607406
- Sponsor's protocol ID
- IRB00119512
- Other IDs
- ONC-HN-2406
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Accelerated Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC (Head and Neck Squamous Cell Carcinoma) Initiating Radiotherapy Greater Than 6 Weeks After Surgery (PORTRush)
- ClinicalTrials.gov ID
- NCT06607406
- Acronym / sponsor ID
- IRB00119512
- Keywords
- Radiotherapy, Accelerated radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine whether accelerated radiotherapy (involving 6 treatments per week) is better than standard radiotherapy (involving 5 treatments per week) at treating cancer of the head and neck when initiated more than 6 weeks after surgery.
Detailed description
This study is a randomized trial designed to determine the effect of Accelerated Fractionation (AF) versus Conventional Fractionation (CF) PORT on locoregional recurrence-free survival, progression-free survival, overall survival, toxicity, and treatment package time in participants with resected intermediate and high-risk Head and Neck Squamous Cell Carcinoma (HNSCC) planned to start Post Operative Radiotherapy (PORT) greater than six weeks after surgery. Eligible participants in both cohorts will be randomized 1:1 to receive five fractions per week of standard conventional fractionation radiotherapy or six fractions per week of accelerated fractionation radiotherapy. If randomized to the standard conventional fractionation group, participants will be treated with five fractions of radiation per week, received daily. If randomized to the accelerated fractionation group, participants will be treated with 6 fractions of radiotherapy per week, received daily and twice daily treatments on one day of the week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional fractionation (5 Fractions) | Active comparator | Radiation: Conventional radiotherapy5 fractions per week, daily treatment Monday-Friday; dosage at the discretion of the treating radiation oncologist per standard of care |
| Accelerated fractionation (6 Fractions) | Experimental | Radiation: Accelerated radiotherapy6 fractions per week, daily treatment plus twice daily treatment for 1 day Monday-Friday; dosage at the discretion of the treating radiation oncologist per standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated radiotherapy6 fractions per week, BID fractions one day per week | Radiation | Accelerated fractionation (6 Fractions) |
| Conventional radiotherapy5 fractions per week, daily M-F | Radiation | Conventional fractionation (5 Fractions) |
Primary outcome
Locoregional Recurrence-free Survival
Time frame: 2 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.
9 secondary outcomes
Progression free survival (PFS)
Time frame: up to 5 years
Overall survival (OS)
Time frame: up to 5 years
Acute and late toxicities
Time frame: up to 24 months post radiotherapy
Patient Report Outcomes (PRO) - PRO-CTCAE
Time frame: at baseline, end radiotherapy (RT), 3, 6, 12, and 24-months post RT
Patient Reported Outcomes (PRO) - MDASI-HN
Time frame: at End of Radiotherapy (RT), 3, 6, 12, and 24-months post RT
Nutritional Toxicity
Time frame: up to 24 months post Radiotherapy
Time to initiation of Postoperative Radiotherapy (PORT)
Time frame: up to 16 weeks
Treatment package time
Time frame: from surgical resection to end of PORT - up to approx. 165 days
Demographic characteristics of eligible participants
Time frame: Prior to Radiotherapy (Pre-screening and baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Hughes, MD principal investigator
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated radiotherapy and Conventional radiotherapy in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma HNSCC, run by Wake Forest University Health Sciences at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Hughes, MD (336-713-6575, ryhughes@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional Recurrence-free Survival (time frame: 2 years post radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.