Head and Neck Squamous Cell Carcinoma
Conditions
Brief summary
To learn if it is effective to use advanced radiation treatment techniques (stereotactic radiation or "SBRT") to safely deliver a strong dose of radiation to your tumor in a shorter period of time than would typically be feasible with traditional methods.
Detailed description
Objectives: * To compare local progression-free survival following palliation with SBRT versus traditional fractionations in patients with HN SCC deemed ineligible for curative-intent treatment. * To compare pain response, symptom burden, toxicity, local control, progression-free survival, and overall survival between the treatment modalities.
Interventions
RADIATIONStereotactic body radiotherapy
Participants will receive radiation as per the schedule discussed with the study doctor.
RADIATIONTraditional Palliation
Participants will receive radiation as per the schedule discussed with the study doctor.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Willing to provide informed consent * Histologically confirmed squamous cell carcinoma * Primary tumor site in the head and neck (includes oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, salivary gland, and cutaneous subsites as well as tumors of unknown primary site) * Ineligible for curative intent treatment after multidisciplinary evaluation (including evaluation by radiation oncologist and surgeon followed by presentation at multidisciplinary tumor board prior to randomization) * Prior therapy including radiation, surgery, or systemic therapy is permitted unless further radiation is deemed inappropriate by the enrolling physician * Metastatic disease is permitted
Exclusion criteria
* Contraindications to radiotherapy * Pregnant or lactating women 5.0 PRE-TREATMENT EVALUATION * History and physical examination including laryngopharyngoscopy by a radiation oncologist and/or head and neck surgeon within 8 weeks prior to randomization. o Clinical examination will include a detailed description of disease target including measurement where feasible to facilitate response assessment * Documentation of smoking history * Staging imaging within 12 weeks prior to randomization: * Contrast-enhanced CT of the neck and chest or * MRI of the neck with CT of the chest or * Whole body PET/CT * Histological confirmation of squamous cell carcinoma * Pregnancy test for women of child-bearing age, within 2 weeks prior to randomization * Assessment of all baseline symptoms, using CTCAE version 5.0 within 2 weeks prior to randomization. * Assessment of baseline pain score (NRS) and analgesic use (non-opioid and opioid) * Completion of QOL scoring within 2 weeks of randomization * Informed consents must be obtained prior to any study specific activities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires | through study completion; an average of 1 year. | M. D. Anderson Symptom Inventory - Head \& Neck (MDASI-HN) score range from 0/10 (0-symptom has not been present)0 to 10 (10-the symptom was as bad as you can imagine it could be) |
Countries
United States
Contacts
CONTACTJay Reddy, MD,PHD
PRINCIPAL_INVESTIGATORJay Reddy, MD,PHD
M.D. Anderson Cancer Center
Outcome results
None listed