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Radiation Therapy

Shortened Adjuvant Radiotherapy for Throat Cancer

N/A

Recruiting

Led By Alexander Lin, MD

Research Sponsored by Abramson Cancer Center at Penn Medicine

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 tests whether radiation dose can be safely reduced in certain throat cancer patients after surgery and neck dissection.

Who is the study for?

This trial is for adults over 18 with a specific throat cancer (p16+ oropharyngeal squamous cell carcinoma) who've had surgery and some lymph node involvement but no distant spread of the disease. They must have good performance status, which means they can carry out daily activities without significant assistance.Check my eligibility

What is being tested?

The study tests if it's safe to give less radiation after transoral robotic surgery (TORS) and neck dissection in patients with certain throat cancers. It also explores whether avoiding radiation to the area where the tumor was removed is effective.See study design

What are the potential side effects?

Adjuvant radiotherapy may cause skin redness, sore mouth or throat, difficulty swallowing, dry mouth, taste changes, fatigue, and in rare cases more serious effects like damage to surrounding organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Locoregional control

Secondary outcome measures

Dysphagia, as measured by patient-reported outcome

Metastasis free survival

Overall survival

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: RadiotherapyExperimental Treatment1 Intervention

The volume treated to the regional lymphatics will be according to the characteristics of the primary site and involved lymph nodes. The dose of radiotherapy delivered will be 30 Gy, over the course of 10 treatments (5 daily treatments/week). Treatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol.1 In patients requiring treatment of the primary site, reduced dose (30 Gy) will be delivered.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

adjuvant radiotherapy

2018

Completed Phase 3

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,560 Total Patients Enrolled

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor

359 Previous Clinical Trials

104,960 Total Patients Enrolled

Alexander Lin, MDPrincipal InvestigatorAbramson Cancer Center

3 Previous Clinical Trials

126 Total Patients Enrolled

Media Library

Adjuvant Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05714657 — N/A

Squamous Cell Carcinoma Research Study Groups: Radiotherapy

Squamous Cell Carcinoma Clinical Trial 2023: Adjuvant Radiotherapy Highlights & Side Effects. Trial Name: NCT05714657 — N/A

Adjuvant Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05714657 — N/A

Frequently Asked Questions

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

Is there a call for enrollment to this experiment?

"As per the clinicaltrials.gov portal, this investigation is actively searching for participants - first posted on January 30th 2023 and most recently amended on February 2nd 2023."

Answered by AI

Are individuals under fifty years of age allowed to partake in this research?

"This clinical trial is open to adults that are within the 18-99 age bracket. By comparison, there are 77 studies for minors and 2590 trials focusing on elderly populations."

Answered by AI

Is there an eligibility requirement to join this research project?

"This medical experiment is recruiting a total of 104 individuals, aged 18 to 99 years old, who are currently going through squamous cell carcinoma of the head and neck. Additionally, participants must fulfill a series of requirements such as Pathologic T0 (unknown primary), AJCC 7th Ed N0-N2c disease with five positive lymph nodes or less, detectable preoperative plasma ctHPVDNA copy number above 200 copies/mL, undetectable postoperative plasma ctHPVDNA ECOG Performance Status 0-1 and histologically confirmed diagnosis p16+ on immunohistochemistry."

Answered by AI

What is the participant capacity for this research initiative?

"Correct. Clinicaltrials.gov has documentation of this medical trial's recruitment, which began on January 30th 2023 and was most recently modified on February 2nd 2023. The experiment is currently looking for 104 test subjects to be enrolled at 3 distinct research centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Shortened Course Adjuvant Radiotherapy Following TORS

2023. "Shortened Course Adjuvant Radiotherapy Following TORS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05714657.