Actively Recruiting
Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma
Led by Shanghai Zhongshan Hospital · Updated on 2022-10-03
56
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the efficacy and safety of an organ-sparing strategy after neoadjuvant chemoradiotherapy followed by transanal endoscopic microsurgery （TEM） or endoscopic local resection for early low rectal cancer（cT 1-3N0M0）.Besides, the clinical complete response rate and near-clinical complete response rate, organ preservation rate, local recurrence rate, distant metastasis rate and quality of life （QoL） will also be assessed.
CONDITIONS
Official Title
Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical stage cT1-3N0M0 confirmed by CT, MRI, and ultrasound colonoscopy
- Rectal adenocarcinoma confirmed by biopsy with tumor lower edge within 5 cm of the anal edge
- Strong desire to preserve the anus and willingness to accept neoadjuvant treatment
- Suitable for organ preservation strategy after hospital multidisciplinary team discussion
- No previous treatment for rectal cancer including surgery, chemotherapy, or radiotherapy
- No contraindications to chemoradiotherapy
- No other colorectal organic diseases
- Voluntarily signed informed consent
You will not qualify if you...
- Previous treatment for rectal cancer including surgery, chemotherapy, or radiotherapy
- Presence of other colorectal organic diseases
- Familial polyposis
- History of colorectal surgery or pelvic radiotherapy that may affect treatment outcomes
- Pregnant or lactating women
- Inability of patient or family to understand study conditions and objectives
- History of uncontrolled epilepsy, CNS diseases, or mental disorders affecting consent or medication compliance
- Tumor characteristics unlikely to achieve complete remission (e.g., tumor >4 cm, suspicious lateral lymph nodes, high baseline CEA, certain pathology types)
- Severe heart disease (e.g., symptomatic coronary disease, NYHA grade II or above heart failure, recent myocardial infarction)
- Organ transplantation requiring immunosuppressive therapy
- Serious uncontrolled infections or other serious diseases
- Blood and biochemical test results outside specified safety limits (e.g., low hemoglobin, low neutrophils, abnormal liver/kidney function)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jian Wang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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