Long-term outcomes for rectal cancer patients treated with organ preservation methods
Official title: Longterm Functional Outcomes in Patients Undergoing Organ Preserving Treatment for Rectal Cancer With or Without Local Excision After Chemoradiotherapy
Run by Insel Gruppe AG, University Hospital Bern · NCT06249672 · Data updated 2026-11-12
This study tests how well organ-preserving treatments work for rectal cancer patients who respond well to initial therapy, helping them avoid major surgery and improve their long-term quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | January 17, 2023 |
| Main results expected | January 16, 2028 |
| Study ends | January 16, 2028 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT06249672 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old with rectal cancer located within 12 cm of the anal verge who have shown a near-complete response to neoadjuvant chemoradiotherapy.
✕Probably not a fit
Patients who are unable to provide informed consent or those for whom follow-up is not feasible 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 study examines the long-term functional outcomes of patients with rectal cancer who undergo organ-preserving treatments after receiving neoadjuvant chemoradiotherapy. It focuses on patients who demonstrate a near-complete response to treatment, allowing them to avoid major surgical procedures. The study aims to evaluate the effectiveness and safety of these organ preservation strategies, which may include local excision, in comparison to traditional surgical options. By analyzing patient outcomes, the study seeks to provide insights into the viability of organ preservation as a standard treatment approach.
Why it matters
Potential benefit: If successful, this study could provide a safer treatment option for rectal cancer patients, reducing the need for invasive surgeries and preserving quality of life.
How similar studies have gone: Previous studies have shown promising results for organ preservation strategies in rectal cancer treatment, indicating that this approach is gaining traction in clinical practice.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>18 years of age * Informed consent * Diagnosis of rectal cancer, \<12cm from anal verge * Treatment by chemoradiation (short course 5x5 Gy or 28x1.8 Gy with concomitant 5FU) * Re staging with MRI/endoscopy shows (near) complete response (max 2cm tumor scar) * Decision for treatment by organ preservation strategy (with or without local excision) Exclusion Criteria: * Inability to give consent * Follow-up not possible
Where it's running
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Bern University Hospital, Inselspital
Bern, Switzerland Recruiting
Study contacts
- Principal investigator: Andreas Kohler, MD — Insel Gruppe AG, University Hospital Bern
- Study coordinator: Andreas Kohler, MD
- Email: andreas.kohler@insel.ch
- Phone: 0041316322111
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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.