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Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer - Trial NCT06209099

Access comprehensive clinical trial information for NCT06209099 through Pure Global AI's free database. This phase not specified trial is sponsored by Peking University Cancer Hospital & Institute and is currently Recruiting. The study focuses on Rectal Cancer. Target enrollment is 67 participants.

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NCT06209099
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Trial Details
ClinicalTrials.gov โ€ข NCT06209099
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Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer

Study Focus

Rectal Cancer

Nonoperative Management (NOM)

Interventional

procedure

Sponsor & Location

Peking University Cancer Hospital & Institute

Beijing, China

Timeline & Enrollment

N/A

Dec 05, 2023

Nov 01, 2025

67 participants

Primary Outcome

Organ-preservation rate

Summary

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 defined low-risk rectal cancer
 following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus
 consolidation CapeOX? Participants will receive radical surgery, LE, or NOM based on the
 response of neoadjuvant intensity modulated radiotherapy with concurrent capecitabine
 plus consolidation CapeOX in patients with MRI defined low-risk rectal cancer.

ICD-10 Classifications

Malignant neoplasm of rectum
Carcinoma in situ: Rectum
Benign neoplasm: Rectum
Secondary malignant neoplasm of large intestine and rectum
Carcinoma in situ: Rectosigmoid junction

Data Source

ClinicalTrials.gov

NCT06209099

Non-Device Trial