Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Short course radiation therapy for patients who have undergone surgery

Short course radiation therapy for patients who have not had surgery

15 fractions of 2.7 Gy per fraction daily over 3 weeks for a total of 40.5 Gy to the post-operative bed and/or necks.

Adjuvant hypofractionation

15 fractions of 3 Gy per fraction daily over 3 weeks for a total of 45 Gy to regions of gross disease. Elective areas can be treated to 37.5 Gy in 15 fractions.

Definitive Hypofractionation

Richard L. Bakst, MD

Lynda N. Rath

Carol White

Jerry Liu, MD

Vishal Gupta, MD

Pinaki Dutta, MD

The purpose of this research study is to investigate a shorter radiation treatment schedule for head and neck cancers in patients 70 years of age and older.

Standard radiation treatment for head and neck patients normally requires that the patient travel to the hospital daily for 6-7 weeks to receive radiation treatment 5 days per week. This long course of radiation can lead to significant side effects resulting in some people being unable to complete the course of treatment. If this happens, and there are gaps in the radiation treatment, this can lead to worse outcomes.

This is a non-randomized pilot study examining the objective response rate and tolerability of short-course radiotherapy (RT) in elderly patients who are unfit for standard conventional fractionation treatment with head and neck squamous cell carcinoma (HNSCC). There will be two unrelated cohorts in this study: definitive RT and adjuvant RT. Patients will be assigned to the cohorts based on their surgical or non-surgical candidacy. The primary study measure is the locoregional control (LRC) rate of patients at 6 months post RT treated with short-course RT. Locoregional control at one year will be determined by radiographic (PET/CT) and clinical assessment of disease. For the definitive cohort, LRC will be defined as regression in size or disappearance of primary tumor and/or lymph nodes on imaging or clinical examination; and for the adjuvant cohort, LRC will be defined as absence of disease on imaging or no clinical evidence of disease.

To further investigate the treatment regimen, the study team will assess the safety of short-course RT and determine the incidence of serious complications, overall survival (OS), disease-free survival (DFS) within 1 year, and the change in quality of life (QoL) in these patients who are unfit for standard conventional fractionation treatment with head and neck squamous cell carcinoma (HNSCC) as secondary objectives. Secondary endpoints will include 1- year overall survival (OS), 1-year disease-free survival (DFS), and the total score of the Functional Assessment of Cancer Therapy-Head and Neck questionnaire (FACT-H\&N). DFS will be defined from the completion of treatment until disease recurrence locally, regionally and/or distantly or until death from disease. OS will be defined from the RT to death or to last follow-up.

As a safety endpoint, the study team will calculate number and proportion of patients developing reportable AEs and SAEs according to relatedness to the treatment and stratified by severity.

Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma

A Non-Randomized, Open-Label, Multi-Center Pilot Study Evaluating Hypofractionation Radiation Therapy in Head and Neck Squamous Cell Carcinoma

All of the individual participant data collected during the trial, after deidentification.

For the adjuvant cohort: LRC will be defined as absence of disease on imaging or no clinical evidence of disease. For the definitive cohort: LRC will be defined as regression in size or disappearance of primary tumor and/or lymph nodes on imaging or clinical examination.

1 year overall survival of patients as defined by completion of treatment until death at 1 year.

1 year disease free survival of patients as defined by completion of treatment until disease recurrence locally, regionally and/or distantly or until the time of death due to disease assessed via PET scan and physical exam.

University of Washington Quality of Life Questionnaire (UW-QOL) full scale from 0 to 100, with higher score indicating poorer health outcomes.

Foundation for the Accreditation of Cellular Therapy-Head and Neck (FACT-H\&N) questionnaire, 38-item instrument. Full scale from 0 to 144, with higher score indicating better quality of life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma	NCT04284540	Head and Neck S...	Adjuvant hypofr... Definitive Hypo...	70 Years -	Icahn School of Medicine at Mount Sinai
Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma	NCT04284540	Head and Neck S...	Adjuvant hypofr... Definitive Hypo...	70 Years -	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for adjuvant hypofractionation