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NCT06328361
Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer
Conditions: Rectal Cancer, Rectal Adenocarcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Tampere University Hospital
Location: East Tallinn Central Hospital Tallinn
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 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
Source: ClinicalTrials.gov (NCT06328361). StuddyBuddy aggregates publicly available trial information.
