Feasibility of Non-Operative Management of Rectal Cancer in a Rural Population
Recruiting · NCT04245683 · Observational (researchers observe without assigning treatment) · Lead sponsor: Bassett Healthcare
View the official record on ClinicalTrials.gov →Interventions studied
Bowel/rectal resectionnon-operative follow up
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed across 1 US state.
- Bassett Healthcare Network - Cooperstown, New York, United States