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Radiation Therapy

Shorter Radiation Schedule for Head and Neck Cancer

N/A

Recruiting

Led By Richard L. Bakst, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

Non-concurrent chemotherapy

Age ≥ 70 years

Must not have

Any comorbid connective tissue disorder which could aggravate RT associated toxicities (e.g. Scleroderma)

Concurrent chemotherapy or immunotherapy or hormonotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a shorter 3-week radiation treatment schedule to see if it is effective and has fewer side effects than the standard 6-7 week schedule.

Who is the study for?

This trial is for people aged 70 or older with head and neck squamous cell carcinoma (HNSCC), including various stages except the most advanced. They must have a life expectancy over 12 weeks, be fit for radiation therapy, and not have had previous radiation or chemotherapy for HNSCC. Pregnant individuals, those with dementia unable to consent, other current cancers (with some exceptions), or connective tissue disorders are excluded.

What is being tested?

The study tests a shorter schedule of radiation treatment called Hypofractionation in elderly patients with HNSCC. It aims to see if this approach can reduce side effects and improve completion rates compared to the standard daily treatments that last 6-7 weeks.

What are the potential side effects?

While specific side effects aren't listed here, hypofractionated radiotherapy may generally cause skin irritation, fatigue, dry mouth/throat issues due to inflammation of mucous membranes, difficulty swallowing, changes in taste sensation and potential impact on oral health.

Eligibility Criteria

Inclusion Criteria

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

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I am not currently receiving chemotherapy.

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I am 70 years old or older.

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I have not had radiation or chemotherapy for head and neck cancer before.

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This is my first treatment for my condition.

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My head or neck cancer is not at the most advanced stage (IVC5).

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My cancer is confirmed in the head, neck, or related areas.

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I am currently receiving treatment aimed at curing my condition.

Exclusion Criteria

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

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I do not have conditions like Scleroderma that worsen with radiation.

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I am currently receiving chemotherapy, immunotherapy, or hormone therapy.

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I have had radiation therapy on my head or neck.

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I am under 70 years old.

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My cancer has spread beyond my head and neck.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Number of participants with Locoregional Control (LRC)

Secondary study objectives

Disease Free Survival (DFS) rate

FACT-H&N questionnaire

Overall Survival (OS) rate

+1 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

Group I: Definitive Hypofractionated Radiation TreatmentExperimental Treatment1 Intervention

Short course radiation therapy for patients who have not had surgery

Group II: Adjuvant Hypofractionated Radiation TreatmentExperimental Treatment1 Intervention

Short course radiation therapy for patients who have undergone surgery

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

904 Previous Clinical Trials

541,781 Total Patients Enrolled

Richard L. Bakst, MD5.02 ReviewsPrincipal Investigator - Icahn School of Medicine at Mount Sinai

Icahn School of Medicine at Mount Sinai

Media Library

$Definitive Hypofractionation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04284540 — N/A$

$Head and Neck Squamous Cell Carcinoma Research Study Groups: Adjuvant Hypofractionated Radiation Treatment, Definitive Hypofractionated Radiation Treatment$