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

NCT ID: NCT04284540

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2025-06-12

Brief Summary

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.

Detailed Description

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.

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adjuvant Hypofractionated Radiation Treatment

Short course radiation therapy for patients who have undergone surgery

Group Type: EXPERIMENTAL

Adjuvant hypofractionation

Intervention Type: RADIATION

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.

Definitive Hypofractionated Radiation Treatment

Short course radiation therapy for patients who have not had surgery

Group Type: EXPERIMENTAL

Definitive Hypofractionation

Intervention Type: RADIATION

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.

Interventions

Adjuvant hypofractionation

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.

Intervention Type: RADIATION

Definitive 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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Age ≥ 70 years.
• No previous RT or chemotherapy for HNSCC is allowed at time of study entry.
• Life expectancy > 12 weeks.
• Participants must have histologically or cytologically confirmed diagnosis of HNSCC: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown primary)
• All stages (according to National Comprehensive Cancer Network 8th edition for head and neck cancers), except stage IVC5
• Non-concurrent chemotherapy
• First line treatment
• Anyone eligible for definitive or adjuvant based RT therapy
• Adjuvant therapy when histopathological factors (advanced T category, nodal disease, lymphovascular or perineural invasion, high-grade, or positive margins)
• Anyone being treated with curative intent
• Unfit as determined by the treating physician and ECOG performance 1, 2, or 3 (Appendix 2).
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

• Patients < 70
• Metastatic disease outside of the head and neck
• Pregnancy
• Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, or other cancer curatively treated by surgery and with no current evidence of disease for at least 5 years.
• Prior RT of head and neck area
• Concurrent chemotherapy or immunotherapy or hormonotherapy
• Any comorbid connective tissue disorder which could aggravate RT associated toxicities (e.g. Scleroderma)
• In cases where patients cannot consent on their own due to underlying dementia, we can consent the patient's healthcare proxy

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Richard L. Bakst

Associate Professor, Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard L. Bakst, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Downtown Union Square

New York, New York, United States

Mount Sinai Chelsea

New York, New York, United States

Mount Sinai West

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

Countries

United States

Other Identifiers

GCO 19-0499

Identifier Type: -

Identifier Source: org_study_id