Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer
- Conditions
- Cancer, Rectal
- Interventions
- Radiation: Short course radiation therapy
- Registration Number
- NCT04139967
- Lead Sponsor
- University of Rochester
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- 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
- Age under 70 years of age
- Ability and desire to receive definitive surgical intervention
- Ability and desire to receive concurrent chemoradiation therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Elderly rectal cancer patients Short course radiation therapy -
- Primary Outcome Measures
Name Time Method Number of participants who experience a grade 2 adverse event week 5 CTCAE V4.0 will be used to determine the grade 2 AE.
Progression-free survival 5 years Progression will be defined as Radiologic response from MRI or CT scans using RECIST v1.1 criteria.
- Secondary Outcome Measures
Name Time Method Number of participants who received surgery for their cancer 5 years Number of participants with improved symptoms 5 years Symptoms will be documented by the treating physician at each clinical visit for 5 years.
Number of participant who experience metastatic disease 5 years MRI or endoscopy will be used to track metastasis to other parts of the body
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.
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.
Trial Locations
- Locations (1)
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States