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Proton Beam Therapy

Radiotherapy for Head and Neck Cancer

N/A

Waitlist Available

Led By Ryan Hughes, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years at the time of enrollment

ECOG performance status of 0-1

Must not have

Recurrent head and neck cancer after prior courses of definitive RT or surgery followed by postoperative RT/CRT

Active malignancy other than the head and neck cancer to be treated with PORT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find out if having more frequent radiotherapy sessions (6 treatments per week) is more effective compared to the standard schedule (5 treatments per week) in treating head and neck cancer that

Who is the study for?

This trial is for patients with certain head and neck cancers who've had surgery over 6 weeks ago. It's not specified who can't join, but typically those with poor health or other serious conditions might be excluded.

What is being tested?

The study compares two types of radiotherapy: accelerated (6 treatments/week) versus conventional (5 treatments/week), to see which is more effective for head and neck cancer post-surgery.

What are the potential side effects?

Radiotherapy may cause skin irritation, fatigue, dry mouth, difficulty swallowing, changes in taste, and potential damage to nearby organs or tissues.

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 am fully active or can carry out light work.

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My cancer is a type of squamous cell carcinoma located in the head or neck.

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I am scheduled for radiotherapy aimed at curing my cancer after surgery.

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I had surgery to remove all visible head and neck cancer.

Exclusion Criteria

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

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My head or neck cancer has returned after radiation or surgery followed by radiation.

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I have no active cancer other than in my head or neck.

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I have a second head and neck cancer after being treated for a previous one.

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I have had radiation treatment to my head or neck.

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My head and neck cancer has spread and I will receive radiation therapy after surgery.

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It has been over 112 days since my cancer surgery and before starting post-operative radiation.

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I do not have any uncontrolled illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Locoregional Recurrence-free Survival

Secondary study objectives

Acute and late toxicities

Demographic characteristics of eligible participants

Nutritional Toxicity

+6 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: Accelerated fractionation (6 Fractions)Experimental Treatment1 Intervention

6 fractions per week, daily treatment plus twice daily treatment for 1 day Monday-Friday; dosage at the discretion of the treating radiation oncologist per standard of care

Group II: Conventional fractionation (5 Fractions)Active Control1 Intervention

5 fractions per week, daily treatment Monday-Friday; dosage at the discretion of the treating radiation oncologist per standard of care

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Accelerated radiotherapy

2001

Completed Phase 3

~350

0 / 12Eligibility criteria met