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Radiation Therapy

Hypofractionated vs Conventional Radiotherapy for Laryngeal Cancer

N/A

Recruiting

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

Pathologically-proven diagnosis of squamous cell carcinoma in situ, squamous cell carcinoma, or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the glottic larynx.

Clinical stage 0-II (AJCC, 8th edition) with direct laryngoscopy showing no evidence of greater than stage II true glottic larynx cancer and PET/CT or CT neck showing no evidence of regional disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months following treatment

Awards & highlights

Study Summary

This trial compares the side effects of two types of radiation treatments for cancer.

Who is the study for?

This trial is for adults with early-stage laryngeal cancer who haven't had certain surgeries or treatments. They must be able to perform daily activities (ECOG 0-2) and agree to use contraception if of childbearing potential. Excluded are those with advanced disease, prior radiation in the area, heavy smokers, or uncontrolled illnesses.Check my eligibility

What is being tested?

The study compares two types of radiotherapy: LT-SABR (a precise high-dose technique) versus IMRT (a standard method). It aims to see which one patients tolerate better during treatment for laryngeal cancer.See study design

What are the potential side effects?

Potential side effects include skin reactions, throat discomfort, changes in voice quality due to irritation or swelling, fatigue from radiation therapy, and possibly more serious complications depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

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

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I have a confirmed diagnosis of squamous cell cancer in my vocal cords.

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My larynx cancer is in an early stage and hasn't spread according to scans.

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I can take care of myself and perform daily activities.

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I have not had surgery to remove my uterus or both ovaries.

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I am at least 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months following treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months following treatment

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

Treatment Details

Study Objectives

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

Primary outcome measures

To compare the acute toxicity outcomes between patients treated with highly-conformal hypofractionated radiotherapy and conventional radiotherapy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Highly conformal hypofractionated radiotherapyExperimental Treatment1 Intervention

LT-SABR 42.5 Gy in 5 fractions Low-risk: twice/week Moderate-risk: weekly

Group II: Conventional radiotherapyExperimental Treatment1 Intervention

Conventional Radiotherapy 63 Gy in 28 fractions (T1) 65.25 Gy in 29 fractions (T2)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IMRT

2003

Completed Phase 3

~1570

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,668 Total Patients Enrolled

Frequently Asked Questions

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

Is there still availability for individuals to partake in this investigation?

"Contrary to expectation, clinicaltrials.gov states that this medical trial is no longer actively recruiting patients. The study was initially announced on November 1st 2023 and underwent its most recent update in October 6th 2023. Despite this, two other trials are still welcoming volunteers at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy

David Sher 2024. "Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06080503.