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recruitment rates were too low
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly rectal cancer patients | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short course radiation therapy | Radiation | 25 Gray in 5 fractions over 5-7 days |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |