Definitive Hypofractionation for Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Carcinoma+7 More
Definitive Hypofractionation - Radiation
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a shorter 3-week radiation treatment schedule to see if it is effective and has fewer side effects than the standard 6-7 week schedule.

Eligible Conditions
  • Carcinoma
  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 3 years

1 year
Disease Free Survival (DFS) rate
Overall Survival (OS) rate
6 months
Number of participants with Locoregional Control (LRC)
Up to 1 year
FACT-H&N questionnaire
Up to 3 years
University of Washington Quality of Life Questionnaire (UW-QOL)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Definitive Hypofractionated Radiation Treatment
1 of 2
Adjuvant Hypofractionated Radiation Treatment
1 of 2
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Definitive Hypofractionation · No Placebo Group · N/A

Definitive Hypofractionated Radiation Treatment
Radiation
Experimental Group · 1 Intervention: Definitive Hypofractionation · Intervention Types: Radiation
Adjuvant Hypofractionated Radiation Treatment
Radiation
Experimental Group · 1 Intervention: Adjuvant hypofractionation · Intervention Types: Radiation

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
771 Previous Clinical Trials
479,786 Total Patients Enrolled
13 Trials studying Carcinoma
814 Patients Enrolled for Carcinoma
Richard L. Bakst, MD5.02 ReviewsPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai

Eligibility Criteria

Age 65+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have no previous RT or chemotherapy for HNSCC.
You have a life expectancy of at least 12 weeks.
You have a tumor that is surgically resectable and has a pathologically confirmed negative margin.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: October 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.