Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer

The goal of this clinical trial is to test the safety and efficacy of local excision (LE) or non-operative management (NOM) in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX. The main questions it aims to answer are: 1. What is the organ-preservation rate (OPR) after in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX? 2. Is LE or NOM safe and effective in patients with MRI

Trial Details

NCT ID
NCT06209099
Phase
NA
Sponsor
Peking University Cancer Hospital & Institute
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Nonoperative Management (NOM)
  • Local Excision (LE)
  • Total Mesorectal Excision (TME)
Locations (sample)
  • Beijing, Haidian District, China|39.9075,116.39723

Key Eligibility Criteria

  • Age ≥ 18 years and ≤85 years
  • ECOG Performance status 0-1
  • Histologically confirmed diagnosis of adenocarcinoma of the rectum, with tumor differentiation Grade 1-3
  • The distance from down verge of tumor to anal-rectal junction (ARJ) ≤4cm based on MRI, or ≤8 cm based on sigmoidoscopy

For full eligibility, visit ClinicalTrials.gov.

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