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Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT06209099•Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

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

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion 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
•Clinical Stage T2 or T3a or T3b and EMVI (-) and MRF (-) and extra-mesorectal metastatic lymph node (-) based on MRI
•The maximum diameter of the tumor is ≤4cm or the circumferential invasion range is less than 1/3 of the intestinal circumference
•No evidence of distant metastases
•No prior pelvic radiation therapy
•No prior chemotherapy or surgery for rectal cancer
•No active infections requiring systemic antibiotic treatment
+2 more criteria

Exclusion Criteria

•Recurrent rectal cancer
•Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en-bloc resection will not achieve negative margins
•Creatinine level greater than 1.5 times the upper limit of normal
•Patients who have received prior pelvic radiotherapy
•Patients who are unable to undergo an MRI
•Patients with a history of a prior malignancy within the past 5 years, except for well treated basal cell cancer, squamous cell skin cancer, breast cancer, thyroid cancer or small renal cancer, and with DFS \&amp;gt;5 years
•Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA
•Other anticancer or experimental therapy
•Women who are pregnant or breast-feeding
•Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.

Locations (1)

Peking University Cancer Hospital & Institute

Beijing, Haidian District, China

Key Dates

Start Date

January 17, 2024

Primary Completion Date

September 1, 2025

Completion Date

November 1, 2025

Last Updated

June 12, 2025

Enrollment

ESTIMATED participants

Conditions

Rectal Cancer

Interventions

Nonoperative Management (NOM)

PROCEDURE

Local Excision (LE)

PROCEDURE

Total Mesorectal Excision (TME)

PROCEDURE

Contacts

Xiaokang Lei, M.D.

CONTACT

+8610-88196086 lxkpku@163.com

Lin Wang, M.D.

CONTACT

+8613910975011 wanglinmd@foxmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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