Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Rectal Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorBassett Healthcare
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Cooperstown, New York)
StatusRecruiting
StartedFebruary 1, 2020
Main results expectedFebruary 1, 2027
Study endsAugust 1, 2027
Registry record updatedMarch 7, 2023
Trial IDNCT04245683 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.