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Radiation Therapy
Radiation Therapy for Laryngeal Cancer
N/A
Waitlist Available
Led By David Sher, 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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether adding a second dose of radiation therapy to the standard dose can improve tumor control without adding to side effects.
Who is the study for?
This trial is for adults with early-stage squamous cell carcinoma of the glottic larynx, who can consent to treatment. They must have a performance status that allows daily activities and agree to use contraception if applicable. Excluded are those with advanced cancer stages, other head and neck cancers, prior chemo or radiotherapy in the area, heavy smokers, or uncontrolled illnesses.Check my eligibility
What is being tested?
The study tests Stereotactic Ablative Radiotherapy on patients with stage I-II glottic larynx cancer. The aim is to maximize tumor radiation dose while minimizing damage to healthy tissue and preserving patient quality of life.See study design
What are the potential side effects?
Radiation therapy may cause side effects like skin irritation at the treatment site, sore throat, difficulty swallowing, voice changes due to inflammation around vocal cords, fatigue and potential long-term impacts on normal tissues leading to altered quality of life.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of the day.
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I have a confirmed diagnosis of a specific type of throat cancer.
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I am 18 years old or older.
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I agree to use effective birth control during and for 90 days after the study.
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My larynx cancer is in the early stages and has not spread according to scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with local failure following SABR treatment of early glottic larynx cancers
Secondary outcome measures
Cumulative incidence of locoregional failure following SABR
Cumulative incidence of regional failure and distant metastasis
Health-related quality of life following treatment with SABR.
+5 moreSide effects data
From 2013 Phase 3 trial • 397 Patients • NCT0000405478%
Menopausal symptoms
60%
Urinary frequency
52%
Impotence
47%
Late RT Toxicity: Bladder: NOS
39%
Diarrhea NOS
27%
Late RT Toxicity: Bowel: NOS
26%
Fatigue
26%
Late RT Toxicity: Other GU: NOS
21%
Proctitis NOS
21%
Dysuria
14%
Libido decreased
14%
Dermatitis radiation NOS
12%
Late RT Toxicity: Other GI: NOS
12%
Late RT Toxicity: Other: NOS
12%
Hemoglobin decreased
12%
Alanine aminotransferase increased
9%
Gynaecomastia
8%
Urinary retention
7%
Pain-other
7%
Aspartate aminotransferase increased
6%
Rectal bleeding
6%
Constipation
6%
Leukopenia NOS
4%
Edema NOS
4%
Hematuria present
4%
Renal/GU-Other
3%
Arthralgia
3%
Blood creatinine increased
3%
Dyspnea NOS
3%
Dermatitis exfoliative NOS
2%
Nausea
2%
Hyperglycemia NOS
2%
Depression NEC
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Stomatitis
1%
Platelet count decreased
1%
Blood albumin decreased
1%
Weight decreased
1%
Anorexia
1%
Hypocalcemia
1%
Hyponatremia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus Chemotherapy
Trial Design
2Treatment groups
Experimental Treatment
Group I: patient with moderate riskExperimental Treatment1 Intervention
Moderate-risk is defined by:
Planning target volume (PTV) greater than or equal to 10 cc, OR
Smoking within 1 month from registration (no more than 1 pack per day)
Radiation Therapy will be delivered daily for 16 fraction (total 58.08 Gy)
Group II: patient with low riskExperimental Treatment1 Intervention
Low-risk is defined by:
Planning target volume (PTV) less than 10 cc, AND
No reported smoking within 1 month from registration
Radiation Therapy will be delivered twice per week for 5 fractions (total 42.5 Gy)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation therapy
2013
Completed Phase 3
~2850
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,771 Total Patients Enrolled
David Sher, MD4.47 ReviewsPrincipal Investigator - University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
2 Previous Clinical Trials
53 Total Patients Enrolled
1Patient Review
This doctor was careless and my husband paid the price with his life.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread beyond the vocal cord's cartilage.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have more than one primary cancer in my head or neck.I can take care of myself and am up and about more than half of the day.I have a confirmed diagnosis of a specific type of throat cancer.I am 18 years old or older.I am a woman who could become pregnant.I have had chemotherapy for my larynx cancer before.I agree to use effective birth control during and for 90 days after the study.My larynx cancer is at stage III or IV.Women who can have babies need to have a negative pregnancy test within 2 weeks before joining the study.My larynx cancer is in the early stages and has not spread according to scans.I've had radiation in the same area as my current cancer.I can understand and sign the consent form myself, or I have someone legally authorized to do so on my behalf.You smoke more than 20 cigarettes per day.
Research Study Groups:
This trial has the following groups:- Group 1: patient with low risk
- Group 2: patient with moderate risk
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment period for this trial still ongoing?
"This trial, which was initially put on the clinicaltrials.gov website in May 2018 and last edited in February 2022, is not presently enrolling patients. Nevertheless, there are 37 other trials recruiting volunteers at this time."
Answered by AI
What criteria must prospective participants meet in order to be enrolled in this medical trial?
"This research is looking to enroll 28 individuals with glottic carcinoma aged between 18 and 120. The eligibility criteria are as follows: No prior hysterectomy or bilateral oophorectomy; at least one menstrual period in the past 12 months, confirmed diagnosis of squamous cell carcinoma involving the larynx, age over 18 years old, ECOG Performance Status 0-2."
Answered by AI
Does this research have any age restrictions for its participants?
"This clinical trial abides by an age restriction that specifies 18 as the lower limit and 120 as the upper boundary for patient enrollment."
Answered by AI
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