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Radiation Therapy

Shorter Radiation Therapy for HPV-Associated Oropharyngeal Cancer

Phase 1

Waitlist Available

Led By Dominic Moon, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

≤10 pack-year smoking history and not actively smoking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-12 months

Awards & highlights

Study Summary

This trial will study a new, shorter radiation therapy regimen for HPV-associated oropharynx cancer. It will see if it is tolerated and has the same effectiveness as the standard 60 Gy radiation therapy in 30 fractions.

Who is the study for?

This trial is for adults with a specific type of throat cancer linked to HPV. Participants should have a limited smoking history, be in good physical condition, and not be actively smoking. Women who can have children must use birth control and provide a negative pregnancy test before joining.Check my eligibility

What is being tested?

The study tests a less intense form of radiation therapy given over 3 weeks alongside weekly cisplatin chemotherapy. It aims to see if this shorter treatment works well for patients with HPV-related oropharyngeal cancer.See study design

What are the potential side effects?

Possible side effects include skin irritation at the radiation site, fatigue, dry mouth, difficulty swallowing, changes in taste, nausea from chemotherapy, and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have smoked 10 or fewer packs a year and I don't smoke now.

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My throat cancer is confirmed, not spread widely, and p16 positive.

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I can take care of myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximally tolerated dose and fractionation of hypofractionated radiation therapy

Secondary outcome measures

Clinician-reported acute toxicities

Clinician-reported late toxicities

Feeding tube dependence

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hypofractionated radiotherapy with concurrent chemotherapy (weekly cisplatin 40 mg/m2)Experimental Treatment1 Intervention

Level 0: 46.5 Gy in 15 fractions, 5 fractions/week Level -1: 52 Gy in 20 fractions, 5 fractions/week

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,775 Total Patients Enrolled

22 Trials studying Carcinoma

7,347 Patients Enrolled for Carcinoma

Gateway for Cancer ResearchOTHER

45 Previous Clinical Trials

2,546 Total Patients Enrolled

3 Trials studying Carcinoma

105 Patients Enrolled for Carcinoma

Dominic Moon, MDPrincipal Investigator - UT Southwestern Medical Center

University of Texas Southwestern Medical Center

1 Previous Clinical Trials

98 Total Patients Enrolled

1 Trials studying Carcinoma

98 Patients Enrolled for Carcinoma

Media Library

$Hypofractionated intensity modulated radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04580446 — Phase 1$

$Carcinoma Research Study Groups: Hypofractionated radiotherapy with concurrent chemotherapy (weekly cisplatin 40 mg/m2)$

$Carcinoma Clinical Trial 2023: Hypofractionated intensity modulated radiotherapy Highlights & Side Effects. Trial Name: NCT04580446 — Phase 1$

$Hypofractionated intensity modulated radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04580446 — Phase 1$

Frequently Asked Questions

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

Has the FDA sanctioned Hypofractionated intensity modulated radiotherapy?

"The data surrounding the safety of Hypofractionated intensity modulated radiotherapy is limited and therefore our team at Power has only assigned it a score of 1."

Answered by AI

Are new participants being welcomed into this research endeavor?

"As evidenced by the data hosted on clinicaltrials.gov, this trial is presently recruiting participants. The initial posting date was December 17th 2020 and most recent update occurred nearly a year later on December 14th 2021."

Answered by AI

How many individuals are the maximum capacity of this medical trial?

"Affirmative. According to information found on clinicaltrials.gov, the trial is actively recruiting from one site and searching for 24 participants who can meet the criteria since it was first posted in December 17th of 2020. It has been updated most recently on December 14th of 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HYHOPE: De-intensified Hypofractionated Radiation Therapy for HPV-associated Oropharynx Cancer

Dominic Moon 2020. "HYHOPE: De-intensified Hypofractionated Radiation Therapy for HPV-associated Oropharynx Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04580446.