Actively Recruiting
Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer
Led by Peking University Cancer Hospital & Institute · Updated on 2025-06-12
96
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years
- ECOG Performance status 0-1
- Histologically confirmed adenocarcinoma of the rectum with tumor differentiation Grade 1-3
- Tumor distance from anal-rectal junction 4 cm or less by MRI, or 8 cm or less by sigmoidoscopy
- Clinical Stage T2, T3a, or T3b with no extramural vascular invasion, no mesorectal fascia involvement, and no extra-mesorectal metastatic lymph nodes by MRI
- Maximum tumor diameter 4 cm or less or circumferential invasion less than one-third of intestinal circumference
- No distant metastases
- No prior pelvic radiation therapy
- No prior chemotherapy or surgery for rectal cancer
- No active infections requiring systemic antibiotics
- Adequate blood counts and liver function: 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
- Able to read, agree to, and sign informed consent
You will not qualify if you...
- Recurrent rectal cancer
- Primary unresectable rectal cancer invading adjacent organs making negative margin resection impossible
- Creatinine level greater than 1.5 times the upper limit of normal
- Prior pelvic radiotherapy
- Unable to undergo MRI
- History of malignancy within past 5 years except well treated basal cell, squamous cell skin, breast, thyroid, or small renal cancer with disease-free survival over 5 years
- History of arterial thrombotic event within past 6 months including angina, myocardial infarction, transient ischemic attack, or stroke
- Other anticancer or experimental therapy
- Pregnant or breastfeeding women
- Any other medical or psychiatric condition making participation inappropriate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital & Institute
Beijing, Haidian District, China, 100142
Actively Recruiting
Research Team
X
Xiaokang Lei, M.D.
CONTACT
L
Lin Wang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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