Clinical trial NCT06607406: Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC Greater Than 6 Weeks After Surgery
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma HNSCC
Keywords: Radiotherapy
Accelerated radiotherapy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Locoregional Recurrence-free Survival
timeFrame: 2 years post radiotherapy
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: up to 5 years
measure: Overall survival (OS)
timeFrame: up to 5 years
measure: Acute and late toxicities
timeFrame: up to 24 months post radiotherapy
measure: Patient Report Outcomes (PRO) - PRO-CTCAE
timeFrame: at baseline, end radiotherapy (RT), 3, 6, 12, and 24-months post RT
measure: Patient Reported Outcomes (PRO) - MDASI-HN
timeFrame: at End of Radiotherapy (RT), 3, 6, 12, and 24-months post RT
measure: Nutritional Toxicity
timeFrame: up to 24 months post Radiotherapy
measure: Time to initiation of Postoperative Radiotherapy (PORT)
timeFrame: up to 16 weeks
measure: Treatment package time
timeFrame: from surgical resection to end of PORT - up to approx. 165 days
measure: Demographic characteristics of eligible participants
timeFrame: Prior to Radiotherapy (Pre-screening and baseline)
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
city: Milwaukee
country: United States
facility: Advocate Aurora Radiation Oncology
state: Wisconsin
Study officials:
affiliation: Atrium Health Wake Forest Baptist Comprehensive Cancer Center
name: Ryan Hughes, MD
role: PRINCIPAL_INVESTIGATOR
References: