Exploring non-surgical treatment options for rectal cancer in rural areas
Feasibility of Non-Operative Management of Rectal Cancer in a Rural Population
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bassett Healthcare Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Cooperstown, New York) |
| Trial ID | NCT04245683 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with metastatic disease or those who are not candidates for surgery will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cooperstown, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.