Longterm Functional Outcomes in Patients Undergoing Organ Preserving Treatment for Rectal
Treatment of rectal cancer by standard neoadjuvant chemoradiotherapy protocols leads to a complete response in about 15% of patients, or even a higher fraction if radiotherapy is followed by an Oxaliplatin based chemotherapy as published recently. If patient presents with a (near) complete response at the time of resta
| Condition(s) | Rectal Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Treatment of rectal cancer by standard neoadjuvant chemoradiotherapy protocols leads to a complete response in about 15% of patients, or even a higher fraction if radiotherapy is followed by an Oxaliplatin based chemotherapy as published recently. If patient presents with a (near) complete response at the time of restaging after neoadjuvant treatment, an organ preservation strategy can be an alternative treatment to low anterior resection or abdominoperineal excision of the rectum. An organ preserving strategy is an ideal option for patients that are too frail for a major oncological resection. Furthermore, organ preservation is increasingly an option for a broader spectrum of patients as there is growing evidence that it allows to avoid surgical risks, including major dysfunction of the u |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Insel Gruppe AG, University Hospital Bern |
| Locations | Bern, Switzerland |
| Start date | 2023-01-17 |
| NCT ID | NCT06249672 |
| Official listing | https://clinicaltrials.gov/study/NCT06249672 |