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Shortened Radiation Therapy for Head and Neck Cancer

Phase 1

Recruiting

Led By Etta Pisano, MD

Research Sponsored by American College of Radiology

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 from the start of h-port up 12 months post-radiation

Awards & highlights

Study Summary

This trial tests if a shorter radiation therapy is safe for certain head & neck cancers after surgery.

Who is the study for?

This trial is for individuals who've had surgery for intermediate-risk head and neck cancer, specifically squamous cell carcinoma. Eligible participants should not have distant metastases, must have completed a total resection of the cancer with no residual disease, and can't have hypopharynx primaries due to higher complication risks.Check my eligibility

What is being tested?

The study is testing if a standard dose of radiation therapy can be safely given over a shorter period following surgery in patients with intermediate-risk head and neck cancer. This approach is called hypofractionated postoperative radiotherapy.See study design

What are the potential side effects?

While specific side effects are not listed here, generally radiation therapy may cause skin irritation at the treatment site, fatigue, dry mouth or throat issues depending on the area treated, difficulty swallowing, and changes in taste.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of h-port up 12 months post-radiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of h-port up 12 months post-radiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of h-port up 12 months post-radiation for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Dose-Limiting Toxicity (DLT)

Secondary outcome measures

Incidence of Adverse Events

Rate of radiation discontinuations

Rate of radiation interruptions

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hypofractionated Postoperative Radiotherapy (H-PORT)Experimental Treatment1 Intervention

H-PORT of 50 Gy given over 4 weeks.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

RTOG Foundation, Inc.OTHER

6 Previous Clinical Trials

1,497 Total Patients Enrolled

American College of RadiologyLead Sponsor

22 Previous Clinical Trials

8,054,231 Total Patients Enrolled

RTOG FoundationUNKNOWN

Frequently Asked Questions

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

Is enrollment for this clinical trial available at this time?

"Indeed, the information on clinicaltrials.gov indicates that this medical trial is currently recruiting participants. This study was first posted in November 8th 2023 and its postings have been recently renewed for the same date - aiming to find 15 new patients from a single location."

Answered by AI

Is this experiment accommodating individuals older than thirty years old?

"The cut-off age range for this trial is between 18 and 75. For the cohort below 18, there are 103 studies while 3131 have been completed for those 65 and above."

Answered by AI

Is H-PORT a safe and effective approach to postoperative radiotherapy?

"The available evidence on Hypofractionated Postoperative Radiotherapy (H-PORT) safety is limited, resulting in a score of 1. This indicates that it is currently undergoing initial testing for viability and efficacy."

Answered by AI

What eligibility criteria is necessary for participation in this clinical trial?

"This clinical trial is currently open to 15 people aged 18-75 who are suffering from head and neck cancer. Furthermore, participants must satisfy these additional criteria: Invasion of the perineural region; a histologically verified diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, or Not Otherwise Specified (NOS) cancers); being classified between clinical stages II to IVA according to AJCC 8th edition protocols; having undertaken a general history physical examination and chest X-Rays/CT Scans/PET CT scans prior too registration; total resection with close margins"

Answered by AI

How many participants are being granted admittance to this trial?

"Indeed, the clinicaltrials.gov record indicates that this medical experiment is actively enrolling patients. It was initially posted on November 8th 2023 and has recently been updated to reflect changes in eligibility criteria or other findings since its inception. Currently, 15 participants are needed across 1 site of recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Safety of Giving a Standard Dose of Radiation Over a Shorter Period of Time for Patients Who Had Surgery for Intermediate-Risk Head and Neck Cancer

2023. "Testing the Safety of Giving a Standard Dose of Radiation Over a Shorter Period of Time for Patients Who Had Surgery for Intermediate-Risk Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05540899.