Cancer, Rectal
Conditions
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.
Interventions
RADIATIONShort course radiation therapy
25 Gray in 5 fractions over 5-7 days
Sponsors
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 5 years | 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 | week 5 | CTCAE V4.0 will be used to determine the grade 2 AE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean quality of life | baseline to 24 months | 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 participant who experience metastatic disease | 5 years | MRI or endoscopy will be used to track metastasis to other parts of the body |
| Number of participants with improved symptoms | 5 years | Symptoms will be documented by the treating physician at each clinical visit for 5 years. |
| Change in Mean functional status | baseline to 24 months | 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 who received surgery for their cancer | 5 years | — |
Countries
United States
Outcome results
None listed