Feasibility of Non-Operative Management of Rectal Cancer in a Rural Population
Bassett Healthcare
50 participants
Feb 1, 2020
OBSERVATIONAL
Conditions
Summary
This is an observational research study. Patients with rectal cancer can choose different courses of treatment. This study will follow these patients over the course of approximately six years, depending on their treatment. Patients will be monitored through clinic visits and survey assessments to see how they do, how they feel regarding their treatment choices, and their outcomes. The surveys will analyze the impact of the patients' treatment choices, as well as patient adherence, in a rural setting.
Eligibility
Inclusion Criteria10
- For a patient to be considered eligible for this study, ALL of the following conditions must be met:
- Age 18 or greater
- ECOG PS 0-2
- Stage II or III, newly diagnosed, biopsy proven, rectal cancer
- No prior treatment for rectal cancer
- No prior pelvic radiotherapy
- Willing to undergo study related testing and monitoring after treatment
- Women of childbearing potential must rule out pregnancy within 2 weeks prior to registration with a blood test or urine study
- Women must not be pregnant or breastfeeding
- Able to provide informed consent
Exclusion Criteria4
- Patients are NOT considered eligible for this study if any of the following conditions apply:
- Patients with metastatic disease
- Patients that are not candidates for surgery
- Patients that refuse neoadjuvant treatment
Interventions
surgical removal of the portion of the rectum where the tumor was originally identified
patients who choose the non-operative option will be required to adhere to a very intensive follow up protocol, including endoscopy and CT imaging
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04245683