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Radiation Therapy
Intensity modulated radiation therapy (IMRT) for Head and Neck Squamous Cell Carcinoma
Phase 2
Waitlist Available
Led By David J Sher, MD, MPH
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether omitting the elective neck treatment (a longstanding standard-of-care) improves toxicity in patients with mucosal squamous cell carcinoma of the head and neck.
Who is the study for?
Adults diagnosed with squamous cell carcinoma of the oropharynx, larynx, or hypopharynx can join this trial. They must have measurable disease and be in good physical condition (ECOG 0-2). Pregnant women are excluded, and participants must agree to use contraception. Those with distant metastasis, prior chemotherapy for the study cancer, other recent malignancies, severe illnesses that could affect participation, or a history of severe allergies to similar drugs cannot participate.Check my eligibility
What is being tested?
The trial is testing intensity modulated radiation therapy (IMRT) focused only on involved and suspicious nodes in head and neck cancer patients. It's a phase II study aiming to see if targeting fewer areas reduces side effects while still being effective against the cancer.See study design
What are the potential side effects?
Potential side effects from IMRT may include skin reactions at the treatment site, dry mouth or throat due to salivary gland exposure, difficulty swallowing if esophageal tissue is affected, fatigue from radiation energy expenditure on cells and possible mild hair loss within irradiated area.
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
To determine the risk of solitary elective volume recurrence following elective volume reduction using INRT.
Secondary outcome measures
Comparison of SEVR risks by p16 status and anatomic site
EORTC HN35 Dry mouth and sticky saliva subscales
EORTC QLQ-C30 Physical and role functioning subscales
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PET-CT at 3 months and ENT evaluationExperimental Treatment1 Intervention
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity modulated radiation therapy (IMRT)
2019
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,732 Total Patients Enrolled
David J Sher, MD, MPHPrincipal InvestigatorUT Southwestern Medical Center
1 Previous Clinical Trials
10,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have early-stage cancer in your vocal cords (glottic carcinoma).You may need to have a surgical procedure to remove a small stage 1 or 2 tonsil or base of tongue cancer.You have other types of cancer in different parts of your body, except for certain types of prostate and thyroid cancer. If you have thyroid cancer, you can have surgery before or after the treatment, as long as you meet all the other requirements.You have had allergic reactions to similar drugs used in this study before.The entire cancerous area, including the main tumor and nearby lymph nodes, has been surgically removed.
Research Study Groups:
This trial has the following groups:- Group 1: PET-CT at 3 months and ENT evaluation
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.
Has the U.S. Food & Drug Administration sanctioned Intensity modulated radiation therapy (IMRT)?
"The safety of Intensity Modulated Radiation Therapy (IMRT) was rated 2 out of 3 due to the limited number of Phase 2 trials that have collected data on its efficacy."
Answered by AI
Are individuals currently being invited to participate in this experiment?
"As per the information posted on clinicaltrials.gov, this medical trial has stopped recruiting participants. It was initially published in July 2019 and last edited November 2022. However, there are still 2676 other trials actively seeking patient volunteers at present."
Answered by AI
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