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Radiation Therapy
Adaptive Radiation Therapy for Oropharyngeal Cancer (OPC-V Trial)
N/A
Waitlist Available
Led By Stuart Samuels, MD, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
OPC-V Trial Summary
This trial tests if an MRI-equipped radiation machine can treat HPV-positive throat tumors.
Who is the study for?
This trial is for individuals newly diagnosed with HPV-positive oropharyngeal cancer (cancers in parts of the throat) who are at an early stage (Stage I-III) and have not had previous treatments. Participants must be able to consent, use contraception if applicable, and tolerate MRIs without sedation.Check my eligibility
What is being tested?
The study is testing the feasibility of using a specialized machine called MRIdian Linac that combines MRI imaging with radiation therapy to treat throat cancer caused by HPV. The goal is to see how well this technology plans and delivers treatment.See study design
What are the potential side effects?
While specific side effects are not listed for this trial, radiation therapy can generally cause soreness or ulcers in the mouth or throat, difficulty swallowing, dry mouth, changes in taste, nausea, fatigue, skin reactions where treated.
OPC-V Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluation of deformable imaging registration
Percent difference between initial reference plan and adaptive weekly RT plan
Secondary outcome measures
Patient-reported Quality of Life as measured by the European Organization for Research and Treatment Head & Neck 43
Patient-reported Quality of Life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30)
Treatment times recorded in minutes
OPC-V Trial Design
1Treatment groups
Experimental Treatment
Group I: MRIdian Linac GroupExperimental Treatment1 Intervention
All accrued participants will be enrolled onto the MRIdian Linac Group. Participants will receive adaptive radiotherapy (ART) on the MRIdian Linac. Participants will complete the duration of their radiotherapy regimen on the MRIdian Linac for approximately 7 weeks.
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Who is running the clinical trial?
University of MiamiLead Sponsor
899 Previous Clinical Trials
409,666 Total Patients Enrolled
Stuart Samuels, MD, PhDPrincipal InvestigatorUniversity of Miami
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have trouble breathing due to a blocked airway.My cancer has spread to distant parts of my body.My cancer is at an early to mid-stage and I am set for combined chemotherapy and radiation treatment.I have had cancer before, but it wasn't a non-melanoma skin cancer.I need some help with my daily activities.I have had surgery, chemotherapy, or radiation for head and neck cancer.My cancer is HPV-positive and located in parts of my throat.I agree to use birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: MRIdian Linac Group
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 this research protocol currently enrolling participants?
"According to clinicaltrials.gov, this medical trial has ceased its patient recruitment efforts after having been posted on July 1st 2023 and last modified on May 5th 2023. Nevertheless, 153 other trials remain open for enrollment."
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