Shorter radiation treatment for elderly patients with head and neck cancer
A Non-Randomized, Open-Label, Multi-Center Pilot Study Evaluating Hypofractionation Radiation Therapy in Head and Neck Squamous Cell Carcinoma
This study is testing a shorter radiation treatment for elderly patients with head and neck cancer to see if it works well and is easier for them to handle.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 4 sites (New York, New York and 3 other locations) |
| Trial ID | NCT04284540 on ClinicalTrials.gov |
What this trial studies
This research investigates a shorter radiation treatment schedule for elderly patients aged 70 and older diagnosed with head and neck squamous cell carcinoma (HNSCC). The study is a non-randomized pilot examining the effectiveness and tolerability of hypofractionated radiotherapy, comparing two cohorts: those receiving definitive treatment and those receiving adjuvant treatment. The primary measure is the locoregional control rate at 6 months post-treatment, with secondary objectives including overall survival, disease-free survival, and quality of life assessments. The goal is to provide a more manageable treatment option that minimizes side effects and improves patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients aged 70 and older with a confirmed diagnosis of head and neck squamous cell carcinoma who are unfit for standard radiation treatment.
Not a fit: Patients under 70 years of age or those with metastatic disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and tolerable treatment option for elderly patients with head and neck cancer.
How similar studies have performed: Other studies have shown promise with hypofractionated radiotherapy in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York and 3 other locations
- Mount Sinai Downtown Union Square — New York, New York, United States (Recruiting)
- Mount Sinai Chelsea — New York, New York, United States (Recruiting)
- Mount Sinai West — New York, New York, United States (Recruiting)
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Richard L. Bakst, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Richard L. Bakst, MD
- Email: richard.bakst@mountsinai.org
- Phone: (212) 241- 3545
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.