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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Number of participants with Locoregional Control (LRC)

Secondary outcome measures

Disease Free Survival (DFS) rate

FACT-H&N questionnaire

Overall Survival (OS) rate

+1 more

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

861 Previous Clinical Trials

525,236 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

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

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

$Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Definitive Hypofractionation Highlights & Side Effects. Trial Name: NCT04284540 — N/A$

$Definitive Hypofractionation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04284540 — N/A$

Frequently Asked Questions

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

Could you provide an update on the enrollment status of this research initiative?

"This clinical trial is not taking on new patients, as reflected by the information hosted on clinicaltrials.gov; it was first published in July 2019 and last updated in August 2022. Despite this, there are currently 2677 other studies actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma

Richard L. Bakst 2019. "Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04284540.

All > Squamous Cell Carcinoma