RecruitingNot ApplicableNCT06209099

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


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

96 participants

Start Date

Jan 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a watch-and-wait approach (avoiding surgery if the tumor disappears completely after treatment) works safely for patients with low-risk rectal cancer very close to the anal opening. Patients receive radiation and chemotherapy, and those with complete tumor disappearance may avoid major surgery. **You may be eligible if...** - You are between 18 and 85 years old with a confirmed rectal adenocarcinoma - Your tumor is within 4 cm of the anal sphincter on MRI (or within 8 cm by scope) - Your cancer is stage T2, T3a, or T3b without spread to surrounding structures or lymph nodes - The tumor is no larger than 4 cm in diameter - You have no distant spread of cancer **You may NOT be eligible if...** - Your tumor has spread to the tissue surrounding the rectum or nearby lymph nodes outside the mesorectum - You have distant metastases - You have prior pelvic radiation or surgery that would complicate treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENonoperative Management (NOM)

Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Nonoperative Management (NOM)

PROCEDURELocal Excision (LE)

Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Local Excision (LE)

PROCEDURETotal Mesorectal Excision (TME)

Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Total Mesorectal Excision (TME)


Locations(1)

Peking University Cancer Hospital & Institute

Beijing, Haidian District, China

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NCT06209099


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