← 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

Must not have

Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

SBRT target size > 6 cm in maximum diameter or greater than 100 cc in volume

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Select...

My treatment target is larger than 6 cm or more than 100 cc in volume.

Select...

I am scheduled to receive treatments like G-CSF or Bevacizumab.

Select...

I am HIV-positive and on combination antiretroviral therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Level of circulating activated T cells as an immune correlate of stereotactic treatment

Local Control Rate

Number of Participants with Adverse Events

+4 more

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)

Chills

Fever

Allergic reaction

Bleed (hemorrhage), gastrointestinal

Hearing impaired

Edema, localized

Other, Creatinine decreased

Pain, flank

Muscle weakness lower limb

Drowsiness, unusual (somnolence)

Tiredness (fatigue)

Lymphedema

Thromboembolic event

Abdominal distention

Abnormal sensation in the mouth (oral dysesthesia)

Dry mouth

Gastroesophageal reflux disease

Pain, stomach

Pain, chest, non-cardiac

Lymphocyte count increased

Other, Neutrophil count increase

Other, Protein total decrease

Thrombocytopenia

Weight gain

Hypercalcemia

Hypernatremia

Dizziness

Nerve tingling (paresthesia)

Slow or slurred speech (dysarthria)

Tremor

Rash

Gastroparesis

Flu-like symptoms

Alkaline phosphatase decreased

Blood bilirubin increased

Dehydration

Nerve damage or injury (neuropathy), peripheral sensory

Confusion

Other, axilla boil

Other, hemoglobin decreased

Infusion-related reaction

Arthritis

Generalized muscle weakness

Memory impairment

Movements involuntary

Chronic kidney disease

Cataract

Other, excess in the stool (steatorrhea)

Other, stool discolored, clay color

Gamma-glutamyl transferase (GGT) increased

Hypoglycemia

Urinary incontinence

Urinary urgency

Urine discoloration

Excessive sweating (hyperhidrosis)

100%

80%

60%

40%

20%

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

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

Intensity Modulated Radiation Therapy (IMRT)

2010

Completed Phase 1

~60

Cisplatin

2013

Completed Phase 3

~3120

Stereotactic Body Radiotherapy (SBRT)

2017

Completed Phase 3

~550

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,108 Previous Clinical Trials

357,216 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.