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

ID#: NCT04284540

Age: 70 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: July 03, 2019

End Date: May 01, 2024

Contact Information:
Richard L. Bakst, MD
(212) 241- 3545
Lynda N. Rath
(212) 824-7501
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.
Eligibility: 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