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

NCT04284540 | Completed DMC

• 1 other identifier: GCO 19-0499
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 4

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.

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Keywords

Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Radiotherapy; Over 70 years of age; Elderly; shorter course of radiation treatment

Outcome Measures

Primary Outcomes (1)

• Number of participants with Locoregional Control (LRC)

  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.

  6 months

Secondary Outcomes (4)

• Overall Survival (OS) rate

  1 year

• Disease Free Survival (DFS) rate

  1 year

• University of Washington Quality of Life Questionnaire (UW-QOL)

  Up to 3 years

• FACT-H&N questionnaire

  Up to 1 year

Study Arms (2)

Adjuvant Hypofractionated Radiation Treatment

EXPERIMENTAL

Short course radiation therapy for patients who have undergone surgery

Radiation: Adjuvant hypofractionation

Definitive Hypofractionated Radiation Treatment

EXPERIMENTAL

Short course radiation therapy for patients who have not had surgery

Radiation: Definitive Hypofractionation

Interventions

Adjuvant hypofractionation 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.

Adjuvant Hypofractionated Radiation Treatment

Definitive Hypofractionation 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.

Definitive Hypofractionated Radiation Treatment

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (4)

Mount Sinai Downtown Union Square

New York, New York, 10003, United States

Location

Mount Sinai Chelsea

New York, New York, 10011, United States

Location

Mount Sinai West

New York, New York, 10019, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Study Officials

• Richard L. Bakst, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Radiation Oncology

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 25, 2020
• Study Start: July 1, 2019
• Primary Completion: November 7, 2024
• Study Completion: June 12, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)