Your session is about to expire
← Back to Search
Stereotactic Radiotherapy + Cisplatin for Head and Neck Cancer
Phase 1
Waitlist Available
Led By Jonathan Schoenfeld, MD, MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For Cohort 2: Pathologically proven solid tumor with evidence of metastatic disease, Measurable disease within the head and neck region
Participants must have a pathologic cancer diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new, targeted way of delivering radiation to people with head or neck cancer that has come back or spread.
Who is the study for?
Adults with recurrent or metastatic head and neck cancer, who have measurable disease in the region, can join this trial. They must not have other active cancers (except certain skin cancers or cervical carcinoma in situ), be medically fit for treatment, and have normal organ/marrow function. Pregnant women, individuals with large SBRT target sizes (>6 cm or >100 cc), those on specific medications like Bevacizumab or anti-tumor necrosis factor agents, and HIV-positive patients on antiretroviral therapy are excluded.Check my eligibility
What is being tested?
The study is testing whether adding a high-dose precision radiation 'boost' using Stereotactic Body Radiotherapy (SBRT) to standard treatments like Cisplatin chemotherapy and Intensity Modulated Radiation Therapy (IMRT) improves outcomes for patients with head and neck cancer that has returned or spread.See study design
What are the potential side effects?
Potential side effects include typical reactions to radiation such as skin irritation, fatigue, dry mouth/throat issues due to IMRT; nausea from Cisplatin; plus risks of higher dose radiation including more acute damage to surrounding tissues/organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a solid tumor in my head or neck that has spread and can be measured.
Select...
My cancer has been confirmed through lab tests.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of stereotactic body radiotherapy treatment (SBRT) when given as a boost in combination with cisplatin and intensity modulated radiation therapy (IMRT)
Maximum tolerated dose of stereotactic body radiotherapy treatment (SBRT) when given for disease metastatic to the head and neck
Secondary outcome measures
Level of circulating activated T cells as an immune correlate of stereotactic treatment
Local Control Rate
Number of Participants with Adverse Events
+4 moreSide effects data
From 2022 Phase 3 trial • 27 Patients • NCT01926197100%
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%
Pain, flank
8%
Other, Creatinine decreased
8%
Lymphedema
8%
Hearing impaired
8%
Bleed (hemorrhage), gastrointestinal
8%
Edema, localized
8%
Thromboembolic event
8%
Allergic reaction
8%
Chills
8%
Fever
8%
Drowsiness, unusual (somnolence)
8%
Tiredness (fatigue)
8%
Muscle weakness lower limb
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
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation.
Cohort 2 (patients with metastatic solid tumors of any histology who have targetable lesions within the head and neck) -- Stereotactic Body Radiotherapy (SBRT)
Group II: Cohort 1Experimental Treatment3 Interventions
Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation.
Cohort 1 (patients who have received prior radiation in the head and neck with gross unresectable disease)
Intensity Modulated Radiation Therapy (IMRT) : daily for 6 weeks
Cisplatin will be administered intravenously on predetermined days
Stereotactic Body Radiotherapy (SBRT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Intensity Modulated Radiation Therapy (IMRT)
2010
Completed Phase 1
~60
Stereotactic Body Radiotherapy (SBRT)
2016
Completed Phase 3
~580
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,927 Total Patients Enrolled
Jonathan Schoenfeld, MD, MPH5.02 ReviewsPrincipal Investigator - Brigham and Women's Hospital
Dana-Farber Cancer Institute
1 Previous Clinical Trials
21 Total Patients Enrolled
5Patient Review
Dr. Schoenfeld at Dana Farmer is excellent. They saved my life after I had a Squamous Cell Carcinoma removed from my tongue and multiple lymph nodes from both sides of my neck. They managed my radiation mapping and treatments perfectly. I couldn't recommend them more highly for anyone with head and neck radiation needs.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 2 years.I have a solid tumor in my head or neck that has spread and can be measured.My treatment target is larger than 6 cm or more than 100 cc in volume.I am scheduled to receive treatments like G-CSF or Bevacizumab.My cancer has been confirmed through lab tests.I can take care of myself but might not be able to do heavy physical work.I had radiation on my head/neck over 6 months ago and my cancer came back or spread in that area.I have had cancer before, but it was a different type.I am 18 years old or older.I am HIV-positive and on combination antiretroviral therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this research project still open?
"This trial has already reached its recruitment goal, as evidenced by the last update on April 4th 2022. If you are in search of other studies, there are currently 2017 trials recruiting for head neoplasms and 689 trials enlisting participants for Stereotactic Body Radiotherapy (SBRT)."
Answered by AI
How many participants have been enlisted for this medical experiment?
"At this juncture, there is no current recruitment for this trial. It was first listed on November 1st 2015 and last modified on April 4th 2022. For those seeking alternative studies, 2017 head neoplasms trials are presently recruiting participants as well as 689 Stereotactic Body Radiotherapy (SBRT) opportunities."
Answered by AI
Has Stereotactic Body Radiotherapy (SBRT) been tested for its efficacy in any previous studies?
"Currently, there are 689 clinical trials exploring Stereotactic Body Radiotherapy (SBRT), of which 274 have advanced to the 3rd phase. Studies conducted in this field are predominantly located in Shanghai, however 43234 locations across the globe offer access to SBRT studies."
Answered by AI
What goals are being sought in this investigation?
"The primary endpoint of this trial is to identify the most tolerated dosage of stereotactic body radiotherapy (SBRT) when applied for metastatic head and neck tumours. Secondary objectives include assessing local control rate via CT or PET scans, documenting adverse events with CTCAE v4 criteria, and evaluating patients' social function pre-treatment versus post- treatment utilizing UW-QOL v4 questionnaire scores. These data will be collected over a 12 month period."
Answered by AI
Is Stereotactic Body Radiotherapy (SBRT) a risk-free treatment for patients?
"Our team at Power assigned SBRT a score of 1, signifying that there is limited data validating its safety and efficacy as this is an exploratory Phase 1 clinical trial."
Answered by AI
What maladies can be addressed with Stereotactic Body Radiotherapy (SBRT)?
"SBRT is typically used to treat late-stage ovarian cancer, but it can also help those with testicular cancer that have not responded well to traditional treatments and cases in which patients have stated advance directives."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger