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Radiation Therapy

Stereotactic Body Radiotherapy (SBRT) for Head and Neck Cancers (SHINE Trial)

Phase 2
Waitlist Available
Led By Justin Lee, MD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the fact-hn quesionnaire will be administered at baseline, once during treatment, 6 weeks, 3, 6, 12 months post sbrt treatment. higher scores represent better qualtiy of life.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a focused radiation treatment for patients with advanced head and neck cancer who can't have standard treatments. The treatment uses precise radiation to kill cancer cells in fewer sessions, aiming to control the disease and relieve symptoms.

Eligible Conditions
  • Head and Neck Cancers
  • Skin Cancer
  • Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the fact-hn quesionnaire will be administered at baseline, once during treatment, 6 weeks, 3, 6, 12 months post sbrt treatment. higher scores represent better qualtiy of life.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the fact-hn quesionnaire will be administered at baseline, once during treatment, 6 weeks, 3, 6, 12 months post sbrt treatment. higher scores represent better qualtiy of life. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tumour response rate
Secondary study objectives
Local Control
Number of participants with Acute and Late Toxicity
Quality of Life as measured by the FACT-HN questionnaire

Side effects data

From 2022 Phase 3 trial • 27 Patients • NCT01926197
100%
Fatigue
100%
Aspartate aminotransferase increased
92%
Diarrhea
92%
Platelet count decreased
83%
Anemia
83%
Weight loss
83%
Alkaline phosphatase increased
83%
Nausea
75%
Pain, abdominal
67%
Decreased appetite (anorexia)
67%
Hypertension
58%
Hyperglycemia
58%
Nerve damage or injury (neuropathy)
58%
Hypokalemia
50%
Alanine aminotransferase increased
50%
White blood cell decreased
50%
Hypoalbuminemia
42%
White blood cell (WBC) count elevated (leukocytosis)
42%
Lymphocyte count decreased
33%
Bloating
33%
Edema, peripheral
25%
Vomiting
25%
Bad taste in mouth (dysgeusia)
25%
Hyponatremia
25%
Anxiety
25%
Pain
25%
Constipation
25%
Hypocalcemia
25%
Labored breathing (dyspnea)
17%
Muscle pain (myalgia)
17%
Indigestion (dyspepsia)
17%
Pain, back
17%
Flatulence
17%
General feeling of discomfort (malaise)
17%
Depression
17%
Hair loss, immune-realted (alopecia)
17%
Neutrophil count decreased
17%
Difficulty sleeping (insomnia)
17%
Oral inflammation (mucositis)
8%
Chills
8%
Fever
8%
Allergic reaction
8%
Bleed (hemorrhage), gastrointestinal
8%
Hearing impaired
8%
Edema, localized
8%
Other, Creatinine decreased
8%
Pain, flank
8%
Muscle weakness lower limb
8%
Drowsiness, unusual (somnolence)
8%
Tiredness (fatigue)
8%
Lymphedema
8%
Thromboembolic event
8%
Abdominal distention
8%
Abnormal sensation in the mouth (oral dysesthesia)
8%
Dry mouth
8%
Gastroesophageal reflux disease
8%
Pain, stomach
8%
Pain, chest, non-cardiac
8%
Lymphocyte count increased
8%
Other, Neutrophil count increase
8%
Other, Protein total decrease
8%
Thrombocytopenia
8%
Weight gain
8%
Hypercalcemia
8%
Hypernatremia
8%
Dizziness
8%
Nerve tingling (paresthesia)
8%
Slow or slurred speech (dysarthria)
8%
Tremor
8%
Rash
8%
Gastroparesis
8%
Flu-like symptoms
8%
Alkaline phosphatase decreased
8%
Blood bilirubin increased
8%
Dehydration
8%
Nerve damage or injury (neuropathy), peripheral sensory
8%
Confusion
8%
Other, axilla boil
8%
Other, hemoglobin decreased
8%
Infusion-related reaction
8%
Arthritis
8%
Generalized muscle weakness
8%
Memory impairment
8%
Movements involuntary
8%
Chronic kidney disease
8%
Cataract
8%
Other, excess in the stool (steatorrhea)
8%
Other, stool discolored, clay color
8%
Gamma-glutamyl transferase (GGT) increased
8%
Hypoglycemia
8%
Urinary incontinence
8%
Urinary urgency
8%
Urine discoloration
8%
Excessive sweating (hyperhidrosis)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Modified FOLFIRINOX
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stereotactic Body Radiotherapy (SBRT)Experimental Treatment1 Intervention
The dose prescribed in the study will be 45Gy in 5 fractions, delivered once every 3-4 days, such that treatment is completed within 15 days. (e.g. treatment given on Monday/Thursday/Mon/Thurs/Mon) (Exceptions: treatment duration of up to 18 days will be allowed to account for cancer centre closures and unforeseen patient issues.)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy (SBRT)
2017
Completed Phase 3
~550

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
917 Previous Clinical Trials
2,616,316 Total Patients Enrolled
Juravinski Cancer Centre FoundationOTHER
12 Previous Clinical Trials
1,915 Total Patients Enrolled
Justin Lee, MDPrincipal InvestigatorJuravinski Cancer Centre
2 Previous Clinical Trials
312 Total Patients Enrolled
~7 spots leftby Dec 2025
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