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Adaptive Radiotherapy for Oropharyngeal Cancer
Phase 2
Waitlist Available
Led By Michelle Mierzwa, M.D.
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18
AJCC eighth edition staging stage 1 and stage 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will use PET-CT scans to see if a patient's cancer has shrunk enough before and during radiation treatment to lower the amount of radiation given.
Who is the study for?
This trial is for adults with early-stage HPV-related squamous cell carcinoma of the oropharynx, who are in good physical condition and have not had previous cancer treatments. Participants must have a tumor that shows up on PET scans and be positive for p16 or HPV. They should not be pregnant, must agree to use birth control, and cannot have diabetes that's hard to manage.Check my eligibility
What is being tested?
The study tests whether using PET-CT scans before and during treatment can help lower the amount of radiation therapy needed for patients with HPV-related oropharyngeal cancer. It involves drugs Paclitaxel and Carboplatin along with personalized radiation therapy based on scan results.See study design
What are the potential side effects?
Possible side effects include reactions related to chemotherapy like nausea, fatigue, hair loss, blood count changes; as well as skin irritation, dry mouth, difficulty swallowing due to radiation therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My cancer is in stage 1 or 2 according to the AJCC 8th edition.
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My throat cancer is p16 positive or HPV positive and shows up on FDG scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The percentage of patients with Local Regional Recurrence (LRR) of disease
Secondary outcome measures
Incidence of Toxicity
The proportion of patients alive
The proportion of patients who progress in any location
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: De-escalation TreatmentExperimental Treatment3 Interventions
Patients will initially receive a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions.
Group II: Standard TreatmentActive Control3 Interventions
Patients will receive a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
VA Ann Arbor Healthcare SystemFED
17 Previous Clinical Trials
12,956 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,680 Previous Clinical Trials
40,928,427 Total Patients Enrolled
University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,169 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I can undergo PET/CT scans.My recent blood test shows my bone marrow is working well.My kidney function tests are within normal range.My cancer is advanced, affecting nearby or distant areas.My cancer is in stage 1 or 2 according to the AJCC 8th edition.I have been mostly active and able to carry on all pre-disease activities without restriction recently.My cancer is in the neck but its original source is unknown.I had surgery to remove all visible signs of my cancer, including the primary site and any affected lymph nodes.I am not pregnant and willing to use contraception if of childbearing potential.I had a PET/CT scan for cancer staging within the last 4 weeks.I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.My throat cancer is p16 positive or HPV positive and shows up on FDG scans.I agree to use effective birth control during the study.I have not had treatment for this cancer before, but I may have had chemotherapy for another cancer over 3 years ago.I've had radiation in the same area as my current cancer.My diabetes is not well-managed.
Research Study Groups:
This trial has the following groups:- Group 1: De-escalation Treatment
- Group 2: Standard Treatment
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.
To what extent is this trial impacting the treatment of individuals?
"Affirmative. Clinicaltrials.gov conveys that this research project, which was first uploaded on May 21st 2018, is actively enrolling individuals. Approximately 75 people need to be recruited from 2 different medical facilities."
Answered by AI
What other research has been conducted exploring the application of Radiation Therapy?
"Presently, 1174 trials are ongoing that examine Radiation Therapy. Of those active studies, 332 have reached Phase 3 and encompass 66513 different sites around the world; many of these locales being concentrated in Shanghai."
Answered by AI
Are there still openings for prospective participants in this clinical research?
"This research project is actively recruiting new participants, per the information found on clinicaltrials.gov. This trial was posted in May 2018 and last updated in February 2022."
Answered by AI
Has the US Food & Drug Administration sanctioned radiation therapy?
"The safety of Radiation Therapy was rated a 2 due to the Phase 2 trial; although there is data confirming its security, no research has yet confirmed efficacy."
Answered by AI
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