Status:
COMPLETED
Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Head and Neck Squamous Cell Carcinoma (HNSCC)
Eligibility:
All Genders
70+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2025
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04284540
Start Date
July 1 2019
End Date
June 12 2025
Last Update
June 22 2025
Active Locations (4)
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1
Mount Sinai Downtown Union Square
New York, New York, United States, 10003
2
Mount Sinai Chelsea
New York, New York, United States, 10011
3
Mount Sinai West
New York, New York, United States, 10019
4
Mount Sinai Hospital
New York, New York, United States, 10029