Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer
Nordic ORgan Preservation Pilot Approach - A Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer (NORPPA-1)
Tampere University Hospital
200 participants
May 16, 2024
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria3
- Histopathological verification of primary rectal adenocarcinoma
- Complete clinical response at response assessment after neoadjuvant therapy
- Informed consent to organ preservation study
Exclusion Criteria3
- Evidence of metastatic disease (fulfilling M-class criteria of TNM)
- No neoadjuvant therapy
- Inability to understand the information related to harms and benefits
Interventions
Clinical and imaging surveillance with digital rectal examination and/or endoscopy, rectal MRI and body CT
Locations(13)
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NCT06328361