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Radiation Therapy

Stereotactic Body Radiotherapy (SBRT) for Squamous Cell Carcinoma (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
Age >= 60 years
Patient declined surgery
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

SHINE Trial Summary

This trial is looking at how well a certain type of radiation therapy works to treat squamous cell carcinoma of the head and neck.

Eligible Conditions
  • Squamous Cell Carcinoma
  • Head and Neck Cancers

SHINE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

SHINE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tumour response rate
Secondary outcome measures
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%
Edema, peripheral
33%
Bloating
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%
Hearing impaired
8%
Abdominal distention
8%
Abnormal sensation in the mouth (oral dysesthesia)
8%
Dry mouth
8%
Gastroesophageal reflux disease
8%
Pain, stomach
8%
Chills
8%
Edema, localized
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%
Muscle weakness lower limb
8%
Dizziness
8%
Drowsiness, unusual (somnolence)
8%
Nerve tingling (paresthesia)
8%
Slow or slurred speech (dysarthria)
8%
Tiredness (fatigue)
8%
Tremor
8%
Rash
8%
Lymphedema
8%
Thromboembolic event
8%
Gastroparesis
8%
Fever
8%
Flu-like symptoms
8%
Allergic reaction
8%
Alkaline phosphatase decreased
8%
Blood bilirubin increased
8%
Dehydration
8%
Pain, flank
8%
Nerve damage or injury (neuropathy), peripheral sensory
8%
Confusion
8%
Other, axilla boil
8%
Other, Creatinine decreased
8%
Other, hemoglobin decreased
8%
Bleed (hemorrhage), gastrointestinal
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

SHINE 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)
2016
Completed Phase 3
~580

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
877 Previous Clinical Trials
2,596,022 Total Patients Enrolled
Juravinski Cancer Centre FoundationOTHER
11 Previous Clinical Trials
1,879 Total Patients Enrolled
Justin Lee, MDPrincipal InvestigatorJuravinski Cancer Centre
2 Previous Clinical Trials
298 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
~8 spots leftby Mar 2025