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Personalized Radiotherapy for Oropharyngeal Cancer

N/A
Waitlist Available
Led By Jimmy Caudell, MD, PhD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically proven diagnosis of p16+ or HPV+ squamous cell carcinoma of the oropharynx
Eastern Cooperative Oncology Group Performance Status 0 to 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-3 months post treatment
Awards & highlights

Study Summary

This trial will see if a mathematical model can be used to select a radiation delivery method that will improve the speed of a response.

Who is the study for?
This trial is for adults over 18 with HPV+ or p16+ squamous cell carcinoma of the oropharynx, without distant metastases. Participants must have measurable disease and be able to follow study procedures. Those who've had complete surgical removal of cancer, are pregnant, have distant metastases, previous radiation in the same area, or conditions that may hinder trial completion cannot join.Check my eligibility
What is being tested?
The study tests if a mathematical model can personalize radiotherapy fractionation to improve rapid response rates in treating HPV-related oropharyngeal cancers. It aims to tailor radiation delivery based on individual tumor characteristics.See study design
What are the potential side effects?
While not explicitly stated here, common side effects of radiotherapy may include sore throat, difficulty swallowing, skin redness at treatment site, dry mouth, fatigue and potential long-term impacts like changes in taste and salivary gland function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My throat cancer is linked to HPV and confirmed by tests.
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I can care for myself but may not be able to do heavy physical work.
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My cancer has not spread to distant parts of my body.
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My cancer can be seen or measured on scans.
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My cancer is in an early to mid-stage and has not widely spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-3 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Response at Week 4 of Treatment
Secondary outcome measures
Rate of Complete Response at 2-3 Months

Trial Design

1Treatment groups
Experimental Treatment
Group I: Radiotherapy FractionationExperimental Treatment1 Intervention
Investigators will use an individual patient proliferation saturation index (PSI) to select radiotherapy fractionation (conventional fractionation or hyperfractionation) to improve the likelihood of a rapid response (defined as ≥ 32% reduction in volume at 4 weeks). Radiotherapy fractionation: Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
537 Previous Clinical Trials
134,936 Total Patients Enrolled
Jimmy Caudell, MD, PhDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

Media Library

Personalized Radiotherapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03656133 — N/A
Oropharyngeal Cancer Research Study Groups: Radiotherapy Fractionation
Oropharyngeal Cancer Clinical Trial 2023: Personalized Radiotherapy Highlights & Side Effects. Trial Name: NCT03656133 — N/A
Personalized Radiotherapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03656133 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is registration currently open for this investigation?

"From what is posted on clinicaltrials.gov, it appears that this medical trial has stopped looking for participants. It was initially published on September 26th 2018 and last edited November 2nd 2022. However, 94 alternative studies are still in the process of recruiting patients at present."

Answered by AI
~8 spots leftby Mar 2025