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Radiation
Low-Dose Chemoradiotherapy for Oropharyngeal Cancer
N/A
Waitlist Available
Led By Marshall Posner, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
IHC must be performed in a lab verified by the central laboratory or the slides must be available for review by the central laboratory and PCR must be done in the central laboratory prior to radiotherapy
Stage 3 or 4 disease without evidence of distant metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing a new, lower-dose treatment for HPV+ oropharynx cancer. They want to see if it's effective and if there are any side effects. They also want to find out which patients would benefit most from this treatment.
Who is the study for?
Adults over 18 with HPV+ oropharyngeal cancer that's not been treated before can join. They need a biopsy for testing, no heavy alcohol use in the last 6 months, and good organ function. Pregnant women, those unwilling to use contraception, people with other cancers (except certain types), severe neuropathy or hearing loss, lung disease, recent heart attack or serious illness can't participate.Check my eligibility
What is being tested?
The trial is testing if lower doses of chemoradiotherapy after initial chemotherapy are effective and safe for advanced HPV-related throat cancer patients. It also aims to identify factors predicting who benefits from this approach.See study design
What are the potential side effects?
Potential side effects include typical reactions to chemotherapy like nausea, fatigue, hair loss; radiotherapy may cause skin irritation and soreness in the treated area. The reduced dosage aims to minimize these effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tests were done in a certified lab or can be reviewed by one.
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My condition is advanced but hasn't spread far.
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I haven't had surgery, radiation, or chemo for my head/neck cancer, except for a biopsy or tonsillectomy.
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My cancer is HPV positive and located in the throat, nasal area, or related regions.
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I am fully active or can carry out light work.
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I have at least one tumor that can be measured.
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I am 18 years old or older.
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I can provide tissue samples from my cancer for testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival
Progression Free Survival (PFS)
Secondary outcome measures
Acute Toxicity
Local-regional control (LRC)
Long Term Toxicity
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Reduced Dose RadiationExperimental Treatment2 Interventions
All patients will receive daily radiation treatment with intensity-modulated radiotherapy (IMRT) - PTV56 and PTV50.4. Treatment will be given 5 days per week and will not routinely be delivered on Saturday, Sunday or major holidays unless a treatment is missed during the week due to technical and/or medical reasons. No more than 5 treatments should be given per week.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,433 Total Patients Enrolled
Marshall Posner, MDPrincipal Investigator - Icahn School of Medicine at Mount Sinai
The Mount Sinai Hospital
Medical School - Tufts University, Doctor of Medicine
Boston Medical Center, Residency in Internal Medicine
6 Previous Clinical Trials
710 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lost more than 25% of my weight without trying in the last 2 months.My cancer is HPV positive and located in the throat, nasal area, or related regions.I am not pregnant or breastfeeding and willing to use contraception during and 3 months after treatment.I have no current cancer except possibly treated skin, cervical, or thyroid cancer, or any cancer cured over 5 years ago.My liver, kidneys, and bone marrow are functioning well.I am part of the Quarterback Trial and was chosen for radiotherapy.My condition is advanced but hasn't spread far.I haven't had surgery, radiation, or chemo for my head/neck cancer, except for a biopsy or tonsillectomy.I do not have severe numbness or pain in my hands or feet.My tests were done in a certified lab or can be reviewed by one.I have significant hearing loss.I am a woman who can have children and have a recent negative pregnancy test.I have Gilbert's Disease but no liver damage, and my liver tests are normal except for high bilirubin.I am fully active or can carry out light work.I have at least one tumor that can be measured.I am 18 years old or older.I am not currently receiving any other cancer treatments.I can provide tissue samples from my cancer for testing.
Research Study Groups:
This trial has the following groups:- Group 1: Reduced Dose Radiation
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 it possible for interested participants to join this research endeavor?
"As evidenced by the clinicaltrials.gov site, this medical trial is still open for enrollment. Initially posted on April 25th 2016 and most recently revised August 23rd 2022, it seeks to recruit new participants."
Answered by AI
What is the accepted patient capacity for this clinical examination?
"Affirmative. Clinicaltrials.gov data reveals that recruitment for this clinical trial was launched on April 25th 2016 and the details were most recently amended on August 23rd 2022. 50 participants are being sought at a single site."
Answered by AI
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