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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer, Rectal

Intervention / Treatment
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* Radiation: Short course radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |