Status:
RECRUITING
Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 in...
Eligibility Criteria
Inclusion
- 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
- ANC \> 1.5 cells/mm3, HGB \> 10.0 g/dL, PLT \> 100,000/mm3, total bilirubin ≤ 1.5 x ULN, AST≤ 3 x ULN, ALT ≤ 4 x ULN
- Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
Exclusion
- 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 \>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.
Key Trial Info
Start Date :
January 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06209099
Start Date
January 17 2024
End Date
November 1 2025
Last Update
June 12 2025
Active Locations (1)
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1
Peking University Cancer Hospital & Institute
Beijing, Haidian District, China, 100142