Exploring non-surgical treatment options for rectal cancer in rural areas
Official title: Feasibility of Non-Operative Management of Rectal Cancer in a Rural Population
Run by Bassett Healthcare · NCT04245683 · Data updated 2026-11-12
This study is looking at whether people with rectal cancer in rural areas can safely skip surgery if they respond well to initial treatment, by following their progress over six years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Bassett Healthcare Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Cooperstown, New York) |
| Status | Recruiting |
| Started | February 1, 2020 |
| Main results expected | February 1, 2027 |
| Study ends | August 1, 2027 |
| Registry record updated | March 7, 2023 |
| Trial ID | NCT04245683 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 or older with newly diagnosed, biopsy-proven stage II or III rectal cancer who have not received prior treatment.
✕Probably not a fit
Patients with metastatic disease or those who are not candidates for surgery will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to follow patients with rectal cancer over approximately six years to assess the feasibility of non-operative management in a rural population. Patients will be monitored through clinic visits and surveys to evaluate their treatment choices, adherence, and outcomes. The study focuses on individuals who achieve a complete clinical response to neoadjuvant therapy, exploring the potential to forego surgery without compromising cancer outcomes. Data collected will help understand the impact of treatment decisions in a rural setting, where such approaches have been under-researched.
Why it matters
Potential benefit: If successful, this study could provide insights into effective non-surgical treatment options for rectal cancer, potentially reducing the need for invasive procedures and their associated side effects.
How similar studies have gone: While there is emerging data supporting non-operative management in urban settings, this approach has not been extensively tested in rural populations, making this study a novel exploration.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: For a patient to be considered eligible for this study, ALL of the following conditions must be met: 1. Age 18 or greater 2. ECOG PS 0-2 3. Stage II or III, newly diagnosed, biopsy proven, rectal cancer 4. No prior treatment for rectal cancer 5. No prior pelvic radiotherapy 6. Willing to undergo study related testing and monitoring after treatment 7. Women of childbearing potential must rule out pregnancy within 2 weeks prior to registration with a blood test or urine study 8. Women must not be pregnant or breastfeeding 9. Able to provide informed consent Exclusion Criteria: Patients are NOT considered eligible for this study if any of the following conditions apply: 1. Patients with metastatic disease 2. Patients that are not candidates for surgery 3. Patients that refuse neoadjuvant treatment
Where it's running
-
Bassett Healthcare Network
Cooperstown, New York, United States Recruiting
Study contacts
- Principal investigator: Eric Bravin, MD — Bassett Healthcare
- Study coordinator: Jennifer Victory, RN
- Email: jennifer.victory@bassett.org
- Phone: 6075476965
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Single vs. double stapling and purse-string techniques after rectal cancer surgery
This trial tests whether using a single-stapling method to join the bowel after rectal cancer surgery results in fewer leaks compared with the double-stapling method.
-
DEM301 in advanced colorectal cancer: a first-in-human test
This first-in-human Phase 1 study tests DEM301 in adults with advanced metastatic colorectal cancer to see if it is safe, how it behaves in the body, and whether it shows any signs of activity.
-
Rectal cancer registry to track real-world treatments and outcomes
This registry collects real-world data on how locally advanced rectal cancer is treated in Austria, to see how TNT and dMMR/MSI-H cases are managed and what outcomes occur.
-
Aerobic exercise and guided imagery for bowel problems after rectal cancer surgery
This study tests whether a program of aerobic exercise plus guided imagery helps people with low anterior resection syndrome after rectal cancer surgery.
-
Active surveillance vs chemoradiotherapy after local removal of intermediate-risk T1 rectal cancer
This study tests whether close follow-up alone after local removal of early rectal cancer can match the cancer control of adding chemoradiotherapy, while reducing treatment-related side effects.
-
Different-Dose Short-Course Radiotherapy With CAPOX, PD-1 Blockade, and IL-2 in Locally Advanced Rectal Cancer
This phase II trial tests whether a low-dose short-course radiotherapy combined with CAPOX, a PD-1 blocker, and IL-2 works as well as the standard-dose short-course approach in patients with locally advanced rectal cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.