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

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

NCT ID: NCT06607406

Condition: Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma HNSCC

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck

Conditions: Keywords:
Radiotherapy
Accelerated radiotherapy

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Accelerated radiotherapy
Description: 6 fractions per week, BID fractions one day per week
Arm group label: Accelerated fractionation (6 Fractions)

Intervention type: Radiation
Intervention name: Conventional radiotherapy
Description: 5 fractions per week, daily M-F
Arm group label: Conventional fractionation (5 Fractions)

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Levine Cancer Institute

Address:
City: Charlotte
Zip: 28204
Country: United States

Contact:
Last name: Matthew Ward, MD

Phone: 980-442-1100
Email: matthew.ward@atriumhealth.org

Facility:
Name: Wake Forest Baptist Comprehensive Cancer Center

Address:
City: Winston-Salem
Zip: 27157
Country: United States

Contact:
Last name: Ryan Hughes, MD

Phone: 336-713-6575
Email: ryhughes@wakehealth.edu

Facility:
Name: Advocate Aurora Radiation Oncology

Address:
City: Milwaukee
Zip: 53215
Country: United States

Contact:
Last name: Jeffrey Kittel, MD

Phone: 414-649-6420
Email: jeffrey.kittel@aah.org

Start date: January 2025

Completion date: January 2030

Lead sponsor:
Agency: Wake Forest University Health Sciences
Agency class: Other

Source: Wake Forest University Health Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06607406