Prospective Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer

University of Rochester1 site in 1 country2 target enrollmentJanuary 20, 2020

ConditionsCancer, Rectal

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer, Rectal
Sponsor: University of Rochester
Enrollment: 2
Locations: 1
Primary Endpoint: Number of participants who experience a grade 2 adverse event
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will help determine if a short course of radiation therapy is effective to treat rectal cancer in older patients. A shorter course of radiation treatment may be better tolerated than a longer course or surgery for the treatment of rectal cancer in the elderly.

Registry

clinicaltrials.gov

Start Date

January 20, 2020

End Date

August 3, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Rochester

Responsible Party

Principal Investigator

Haoming (Carl) Qiu

Associate Professor

University of Rochester

Eligibility Criteria

Inclusion Criteria

•70 years or older at time of diagnosis
•No restrictions on gender or ethnicity
•Ability and willingness to make follow up appointments
•Pathologic diagnosis of rectal cancer
•Presentation could be symptomatic or asymptomatic
•T1-T3 primary rectal adenocarcinoma as determined on TRUS, CT, or MRI pelvis
•Peri-rectal node positive allowed
•Inability to tolerate radical surgery, as judged by geriatric oncology or surgeon and tumor board OR patient refusal of surgery
•Inability to receive chemoradiation therapy, defined as concurrent chemotherapy and radiation doses of 45-50.4 Gy, as judged by radiation, medical, or geriatric oncology
•Patients with dementia eligible if Health Care Proxy (HCP) is available and supportive of follow up schedule