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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cancer, Rectal
• Intervention / Treatment: Radiation: Short course radiation therapy

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • James P. Wilmot Cancer Center at University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

• Age under 70 years of age
• Ability and desire to receive definitive surgical intervention
• Ability and desire to receive concurrent chemoradiation therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elderly rectal cancer patients	Radiation: Short course radiation therapy; 25 Gray in 5 fractions over 5-7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression will be defined as Radiologic response from MRI or CT scans using RECIST v1.1 criteria.	5 years
Number of participants who experience a grade 2 adverse event	CTCAE V4.0 will be used to determine the grade 2 AE.	week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who received surgery for their cancer		5 years
Number of participant who experience metastatic disease	MRI or endoscopy will be used to track metastasis to other parts of the body	5 years
Change in Mean quality of life	Quality of life will be assessed using the Low Anterior Resection Syndrome Score Questionnaire. Scores range from 0-42 points with higher scores indicating worse outcome.	baseline to 24 months
Change in Mean functional status	Quality of life will be assessed using the Low Anterior Resection Syndrome Score Questionnaire. Scores range from 0-42 points with higher scores indicating worse outcome.	baseline to 24 months
Number of participants with improved symptoms	Symptoms will be documented by the treating physician at each clinical visit for 5 years.	5 years

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): August 3, 2022
• Study Completion (Actual): August 3, 2022

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 4297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No