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Radiation Therapy
Reduced Radiation Therapy for Oropharyngeal Cancer
N/A
Waitlist Available
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 7th Ed)
Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights
Study Summary
This trial will test if using lower doses of radiation to a smaller area of the head and neck region can help prevent cancer from growing back in the throat or neck.
Who is the study for?
This trial is for adults over 18 with a specific throat cancer (p16+ oropharyngeal squamous cell carcinoma) that hasn't spread too far. They should be in good physical shape and have no more than four affected lymph nodes. People with very advanced disease, distant spread of cancer, previous head/neck radiation, or more than four positive lymph nodes can't join.Check my eligibility
What is being tested?
The study tests if using lower doses of radiation to a smaller area in the head and neck region is effective for treating throat cancer without it coming back within two years. It's a Phase II trial where all participants receive this modified radiation therapy.See study design
What are the potential side effects?
Radiation may cause soreness or ulcers in the mouth or throat, trouble swallowing, dry mouth, changes in taste, fatigue, skin redness and irritation at the treatment site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is at an early or middle stage according to its size and extent.
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My throat cancer is confirmed to be p16 positive.
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My cancer has spread to fewer than 5 lymph nodes.
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I am fully active or can carry out light work.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
2-year locoregional control
Secondary outcome measures
2-year progression-free survival
Differences in toxicity between Intensity-modulated radiation therapy (IMRT) and Intensity Modulated Proton Therapy (IMPT)
Metastasis-free survival
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
All patients will have the volume treated and radiation dose delivered to the regional lymphatics decreased according to the characteristics of the primary site and involved lymph nodes. The high risk neck will receive 50 Gy instead of 60 Gy, and the treated volume of the contralateral low risk neck will be reduced and receive only 45 Gy.
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,494 Total Patients Enrolled
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
104,894 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to distant parts of my body.My cancer is at an early or middle stage according to its size and extent.My cancer has spread to nearby tissues.My throat cancer is confirmed to be p16 positive.My cancer has spread to fewer than 5 lymph nodes.I have had radiation therapy to my head or neck.I am fully active or can carry out light work.I am 18 years old or older.My cancer has spread to lymph nodes in my neck.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
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.
How many subjects are participating in this trial?
"Affirmative. Clinicaltrials.gov reflects that this clinical trial is currently enrolling participants, which began on November 10th 2018 and was most recently amended on December 8 2021. This research project seeks to enlist 150 patients from 1 medical centre."
Answered by AI
Are recruitment efforts currently underway for this research study?
"According to clinicaltrials.gov, this research study is currently recruiting volunteers as it was first posted on October 11th 2018 and then revised on December 8th 2021."
Answered by AI
What dangers can patients expect from IMRT or IMPT radiation treatment?
"Our team at Power assigned a score of 2 to Radiation Therapy (IMRT or IMPT) due to the existence of preliminary safety data, but no clinical efficacy evidence."
Answered by AI
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