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

Primary Purpose

Cancer, Rectal

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Short course radiation therapy
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer, Rectal

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elderly rectal cancer patients

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants who received surgery for their cancer
Number of participant who experience metastatic disease
MRI or endoscopy will be used to track metastasis to other parts of the body
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.
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.
Number of participants with improved symptoms
Symptoms will be documented by the treating physician at each clinical visit for 5 years.

Full Information

First Posted
October 23, 2019
Last Updated
July 12, 2023
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT04139967
Brief Title
Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer
Official Title
Prospective Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
recruitment rates were too low
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
August 3, 2022 (Actual)
Study Completion Date
August 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Rectal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elderly rectal cancer patients
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Short course radiation therapy
Intervention Description
25 Gray in 5 fractions over 5-7 days
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Progression will be defined as Radiologic response from MRI or CT scans using RECIST v1.1 criteria.
Time Frame
5 years
Title
Number of participants who experience a grade 2 adverse event
Description
CTCAE V4.0 will be used to determine the grade 2 AE.
Time Frame
week 5
Secondary Outcome Measure Information:
Title
Number of participants who received surgery for their cancer
Time Frame
5 years
Title
Number of participant who experience metastatic disease
Description
MRI or endoscopy will be used to track metastasis to other parts of the body
Time Frame
5 years
Title
Change in Mean quality of life
Description
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.
Time Frame
baseline to 24 months
Title
Change in Mean functional status
Description
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.
Time Frame
baseline to 24 months
Title
Number of participants with improved symptoms
Description
Symptoms will be documented by the treating physician at each clinical visit for 5 years.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 Exclusion Criteria: Age under 70 years of age Ability and desire to receive definitive surgical intervention Ability and desire to receive concurrent chemoradiation therapy
Facility Information:
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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