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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Tampere University Hospital • ClinicalTrials.gov ID: NCT06328361

Registry updated: 2026-09-30
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Description

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

Interventions

  • Nonoperative surveillance (Procedure)
    Clinical and imaging surveillance with digital rectal examination and/or endoscopy, rectal MRI and body CT

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

Conditions

Rectal Cancer Rectal Adenocarcinoma

Locations

  • East Tallinn Central Hospital — Tallinn, Estonia
  • North Estonia Medical Centre — Tallinn, Estonia
  • West Tallinn Central Hospital — Tallinn, Estonia
  • Tartu University Hospital — Tartu, Estonia
  • Helsinki University Central Hospital — Helsinki, Finland
  • Jyväskylä Central Hospital — Jyväskylä, Finland
  • Kuopio University Hospital — Kuopio, Finland
  • Oulu University Hospital — Oulu, Finland
  • Satakunta Central Hospital — Pori, Finland
  • Seinajoki Central Hospital — Seinäjoki, Finland
  • Tampere University Hospital — Tampere, Finland
  • Turku University Hospital — Turku, Finland
  • Vaasa Central Hospital — Vaasa, Finland
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record