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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

Must not have

Stage I and II glottic squamous cell carcinoma

High risk factors following surgical resection requiring concurrent chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is a stage I or II squamous cell carcinoma of the glottis.

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I need chemotherapy along with surgery due to high risk factors.

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I have a history of severe immune system problems, including HIV, or have had an organ or stem cell transplant.

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I had cancer before and it's likely to return within 3 years.

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I have had radiation therapy on the cancer area being studied.

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I have another type of cancer that is not skin cancer or in the specified areas.

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I do not have any unmanaged ongoing illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Maximally tolerated dose of hypofractionated radiation therapy

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

Secondary study objectives

Clinician-reported acute toxicities

Clinician-reported late toxicities

Feeding tube dependence

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 10Eligibility criteria met