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Hypofractionated IMRT for Head and Neck Cancer

Phase 1 & 2

Recruiting

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

ECOG performance status 0-2

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-24 months

Awards & highlights

Study Summary

This trial is testing a new way to give radiation therapy that may be better than the current standard.

Who is the study for?

This trial is for adults with stage I-IVB squamous cell carcinoma of the oral cavity or related areas, who've had surgery but still have intermediate risk factors. They must be in fair health, able to consent, and use birth control if needed. Excluded are those with distant cancer spread, prior radiation in the area, severe illnesses that affect study compliance, pregnant/nursing women, high-risk surgical outcomes needing chemo, certain immune conditions or other cancers.Check my eligibility

What is being tested?

The HYPORT trial tests a shorter course of post-op radiation therapy (IMRT) for head and neck cancer patients. Phase 1 checks safety and tolerability to find the right dose; Phase 2 compares swallowing quality of life and effectiveness against standard longer-term radiation treatments.See study design

What are the potential side effects?

Potential side effects include skin reactions at the treatment site, dry mouth or throat changes affecting swallowing ability due to inflammation from IMRT. There may also be fatigue and possible acute toxicity as assessed in Phase 1.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of the day.

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I am 18 years old or older.

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I had surgery to remove cancer from my mouth or throat and it was somewhat risky.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-24 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

Phase 1: Maximally tolerated dose of hypofractionated radiation therapy

Phase 2: Swallowing-related patient-reported quality of life

Secondary outcome measures

Clinician-reported acute toxicities

Clinician-reported late toxicities

Feeding tube dependence

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hypofractionated radiotherapyExperimental Treatment1 Intervention

Dose and fractionation determined by Phase I: Level 1: 44.4 Gy in 12 fractions, 4 fractions/week Level 0: 46.5 Gy in 15 fractions, 5 fractions/week Level -1: 52 Gy in 20 fractions, 5 fractions/week Level -2: 50 Gy in 20 fractions, 5 fractions/week

Group II: Conventionally fractionated radiotherapyActive Control1 Intervention

60 Gy in 30 fractions, 5 fractions/week

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,713 Total Patients Enrolled

Dominic Moon, MDPrincipal Investigator - UT Southwestern Medical Center

University of Texas Southwestern Medical Center

1 Previous Clinical Trials

24 Total Patients Enrolled

Media Library

Intensity-modulated Radiation Therapy (IMRT) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04403620 — Phase 1 & 2

$Oral Squamous Cell Carcinoma Research Study Groups: Conventionally fractionated radiotherapy, Hypofractionated radiotherapy$

Intensity-modulated Radiation Therapy (IMRT) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04403620 — Phase 1 & 2

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 patient participation in this research endeavor?

"Affirmative. Clinicaltrials.gov data confirms that this medical experiment, which was first posted on July 28th 2020, is currently seeking participants. Around 98 subjects need to be enlisted from 1 specified clinic."

Answered by AI

Are there opportunities to participate in this investigation?

"Affirmative. According to information published on clinicaltrials.gov, the trial first announced on July 28th 2020 is still looking for 98 participants at a single site and was recently updated on October 7th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer

Dominic Moon 2020. "HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04403620.

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