Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative
The goal of this one-arm clinical trial is to implement and study the oncological outcomes of nonoperative management of rectal cancer having complete clinical response to neoadjuvant therapy. The main questions to answer are * if the oncological results of nonoperative management after Nordic practice in chemoradiothe
| Condition(s) | Rectal Cancer, Rectal Adenocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The goal of this one-arm clinical trial is to implement and study the oncological outcomes of nonoperative management of rectal cancer having complete clinical response to neoadjuvant therapy. The main questions to answer are * if the oncological results of nonoperative management after Nordic practice in chemoradiotherapy indications differ from experiences elsewhere * what is the organ preservation rate * what is the local regrowth rate |
| Who can participate | Inclusion Criteria: * Histopathological verification of primary rectal adenocarcinoma * Complete clinical response at response assessment after neoadjuvant therapy * Informed consent to organ preservation study Exclusion Criteria: * Evidence of metastatic disease (fulfilling M-class criteria of TNM) * No neoadjuvant therapy * Inability to understand the information related to harms and benefits |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Tampere University Hospital |
| Locations | Tallinn, Estonia; Tallinn, Estonia; Tallinn, Estonia; Tartu, Estonia; Helsinki, Finland; Jyväskylä, Finland (+7 more sites) |
| Start date | 2024-05-16 |
| NCT ID | NCT06328361 |
| Official listing | https://clinicaltrials.gov/study/NCT06328361 |