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Radiation Therapy

SBRT with protons or photons for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Henning Willers, MD
Research Sponsored by Massachusetts General Hospital
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 up to 8 years
Awards & highlights

Study Summary

This trial is studying how well SBRT works in treating patients with stage IV NSCLC that has a mutated EGFR or ALK or ROS1 gene.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Oncogenes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1-year Frequency of Original Site Failures (OF) and New Distant Failures (DF) After Stereotactic Body Radiation Therapy (SBRT)
Secondary outcome measures
2-year Local Failure (LF) of Lesions Treated With Stereotactic Body Radiation Therapy (SBRT)
2-year Overall Survival
Median Overall Survival
+1 more

Side effects data

From 2022 Phase 2 trial • 27 Patients • NCT02314364
70%
Diarrhea
59%
Fatigue
52%
Cough
48%
Constipation
44%
Nausea
44%
Lymphocyte count decreased
44%
Dry skin
44%
Dyspnea
41%
Back pain
33%
Headache
33%
Rash acneiform
33%
Pain
26%
Gait disturbance
26%
White blood cell decreased
26%
Insomnia
26%
Edema limbs
26%
Dizziness
26%
Paronychia
22%
Pneumonitis
22%
Productive cough
19%
Alopecia
19%
Fall
19%
Rash maculo-papular
19%
Chills
19%
Non-cardiac chest pain
15%
Pain in extremity
15%
Hyperglycemia
15%
Blurred vision
15%
Anxiety
15%
Fever
15%
Chest wall pain
15%
Gastroesophageal reflux disease
15%
Dry eye
11%
Upper respiratory infection
11%
Palpitations
11%
Paresthesia
11%
Neutrophil count decreased
11%
Memory impairment
11%
Vomiting
11%
Abdominal Distension
11%
Abdominal Pain
11%
Cataract
11%
Alanine aminotransferase increased
11%
Muscle weakness lower limb
11%
Anorexia
11%
Confusion
11%
Hypophosphatemia
11%
Peripheral sensory neuropathy
11%
Dysphagia
7%
Arthralgia
7%
Pleural effusion
7%
Sinus tachycardia
7%
Dermatitis radiation
7%
Dysphasia
7%
Tremor
7%
Urinary retention
7%
Pruritus
7%
Generalized muscle weakness
7%
Allergic rhinitis
7%
Dysgeusia
7%
Hypothyroidism
7%
Skin infection
7%
Tinnitus
7%
Vertigo
7%
Hearing impaired
7%
Watering eyes
7%
Hyponatremia
7%
Weight gain
7%
Apnea
7%
Bruising
7%
Dehydration
7%
Epistaxis
7%
Presyncope
7%
Anemia
7%
Aspartate aminotransferase increased
7%
Esophagitis
7%
Conjunctivitis
7%
Dyspepsia
7%
Blood bilirubin increased
7%
Wheezing
7%
Platelet count decreased
7%
Hyperhidrosis
7%
Erythema multiforme
7%
Localized edema
7%
Malaise
4%
Oculomotor nerve disorder
4%
neurogenic sensory cystopathy
4%
Serum sickness
4%
Transient ischemic attacks
4%
Orthostatic hypotension
4%
Cracking of fingernails
4%
Sore throat
4%
Hemoptysis
4%
Rash pustular
4%
Esophageal pain
4%
Hip fracture
4%
Hot flashes
4%
Hypokalemia
4%
Laryngitis
4%
Musculoskeletal deformity
4%
Pelvic pain
4%
Serum amylase increased
4%
Pulmonary fibrosis
4%
Rhinitis infective
4%
Rectal perforation
4%
Leukocytosis
4%
Alternating exophoria
4%
Lymph gland infection
4%
Osteoporosis
4%
Dermatoheliosis
4%
Hypotension
4%
Dysconjugate gaze
4%
Fecal incontinence
4%
Oral pain
4%
Palmar-plantar erythrodysesthesia syndrome
4%
Papulopustular rash
4%
Pharyngeal mucositis
4%
Seizure
4%
Skin hyperpigmentation
4%
Hypoxia
4%
Leg cramps
4%
Rectal hemorrhage
4%
Hypoalbuminemia
4%
Scalp pain
4%
Urinary frequency
4%
Sinusitis
4%
Hematuria
4%
Neck pain
4%
Abducens nerve disorder
4%
Depression
4%
Muscle weakness right-sided
4%
Ear pain
4%
Urinary tract obstruction
4%
Edema face
4%
Flashing lights
4%
Fracture
4%
Increased neutrophils
4%
Urinary urgency
4%
Alkaline phosphatase increased
4%
Eyelid function disorder
4%
Amnesia
4%
Hoarseness
4%
Hyperkalemia
4%
Hypertension
4%
Lipase increased
4%
Urinary tract infection
4%
Flu like symptoms
4%
Chylothorax
4%
Soft tissue infection
4%
Thromboembolic event
4%
Mucositis oral
4%
Myalgia
4%
Chest pain - cardiac
4%
Hypersomnia
4%
Hepatitis viral
4%
Supraventricular tachycardia
4%
Weight loss
4%
Lower left extremity numbness
4%
Urinary incontinence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy (SBRT) With Protons or Photons

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stereotactic body radiation therapy (SBRT) with protons or photonsExperimental Treatment1 Intervention
SBRT dosage determined by treating physician Patients will continue to receive standard of care (SOC) tyrosine kinase inhibitors (TKI) in the intervals between SBRT courses, as well as after the completion of SBRT If there is more than one active site of cancer, additional site(s) will be treated with stereotactic treatment courses. The total duration of SBRT courses (from the first day of any SBRT course to the last day of any SBRT course) will not exceed 4 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBRT with protons or photons
2014
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,462 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,929 Previous Clinical Trials
13,198,278 Total Patients Enrolled
Henning Willers, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
2 Previous Clinical Trials
31 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
clinicaltrials.govStudy
A Trial of Integrating SBRT With Targeted Therapy in Stage IV Oncogene-driven NSCLC
Henning Willers, M.D. 2014. "A Trial of Integrating SBRT With Targeted Therapy in Stage IV Oncogene-driven NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02314364.
~3 spots leftby Apr 2025
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