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Radiation Therapy
Radiation Therapy for Head and Neck Cancer
Phase 2
Recruiting
Led By Jack Phan
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with histologically documented recurrent head and neck cancer, or second primary head and neck cancer, AND who have previously received radiation (at least 30 Gy) for head and neck cancer
Not eligible for surgery for recurrence or poor surgical candidate
Must not have
a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
b) No myocardial infarction within 3 months of registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two types of radiation therapy to see which is more effective in treating head and neck cancer that has returned.
Who is the study for?
This trial is for adults with head and neck cancer that has returned after treatment. They should be in a condition to undergo radiation (ECOG score 0-2), not pregnant, and have had previous radiation of at least 30 Gy. Candidates must not be suitable for surgery, have visible tumors on scans, and limited sites of recurrence.
What is being tested?
The study compares two advanced types of radiation therapy: Stereotactic Body Radiation Therapy (SBRT) which targets tumors precisely with fewer sessions, and Intensity Modulated Radiation/Proton Therapy (IMRT/PRT) which uses high-energy rays or protons to kill tumor cells.
What are the potential side effects?
Potential side effects include skin reactions, fatigue, dry mouth or throat issues due to damage to surrounding tissues; difficulty swallowing; changes in taste; nausea; inflammation from precise but intense radiation doses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had head and neck cancer before, received radiation, and it has come back or I have a new one.
Select...
I cannot have surgery for my cancer's return due to high risks.
Select...
My cancer has returned in 1-3 places, each smaller than 60 cc and all together under 100 cc.
Select...
I can take care of myself but may not be able to do heavy physical work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have heart problems like heart failure, chest pain, or irregular heartbeat not managed by a pacemaker.
Select...
I have not had a heart attack in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of grade 3+ toxicity (Tox3+) assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Secondary study objectives
Incidence of acute grade 3 or higher toxicity assessed by CTCAE
Incidence of late grade 3 or higher toxicity assessed by CTCAE
Local control defined as absence of local failure
+4 moreAwards & 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: Group II (IMRT/IMPT)Experimental Treatment2 Interventions
Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments.
Group II: Group I (SBRT)Experimental Treatment1 Intervention
Patients undergo SBRT every other day for a total of 5 treatments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2140
Proton Radiation
2010
Completed Phase 2
~220
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,073 Previous Clinical Trials
1,803,227 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,111,993 Total Patients Enrolled
Jack PhanPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials