Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer

Launched by TAMPERE UNIVERSITY HOSPITAL · Mar 18, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to manage rectal cancer without surgery for patients who have shown a complete response to initial treatment, known as neoadjuvant therapy. The trial aims to find out how effective this non-surgical approach is compared to other methods, how well patients can keep their organs intact, and whether there are any cases of cancer returning locally.

To participate in this study, you need to have a confirmed diagnosis of rectal adenocarcinoma and must have responded completely to the neoadjuvant therapy. The trial is open to both men and women aged 65 and older. If you join the trial, you will be monitored closely to track your health and the effectiveness of this treatment method. It's important to know that participants must understand the potential risks and benefits of being in this study, and those with spreading cancer or who haven't received the initial therapy won't be eligible.

Gender

ALL

Eligibility criteria

• 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