rectal cancer
Conditions
Interventions
Experimental:Endoscopic resection+adjuvant chemoradiotherapy
Control:Endoscopic resection+salvage surgery
Sponsors
Zhongshan Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years; 2. No lymph node metastasis or distant metastasis (cN0M0) was evaluated by CT, MRI, PET-CT and other imaging; 3. After endoscopic resection of middle and low rectal mucosal lesions, the pathological diagnosis was rectal adenocarcinoma resected by R0, with high-risk recurrence factors: ? pT1 stage, and meet any of the following conditions: submucosal infiltration depth = 1000 µ M. The lymphatic vessel invasion was positive, the histological differentiation was poor, and the bud grade of the deepest invasion was BD2/3; ? Or pT2 phase; 4. The patient or family member has a strong desire to preserve the anus, refuses to undergo radical surgery, and is suitable for implementing the organ preservation strategy after discussion by the multidisciplinary team of the hospital; 5. Before accepting this endoscopic resection, he did not receive other treatment for the above rectal lesions (including endoscopic resection, local anal resection, radiotherapy, chemotherapy, etc.); 6. ECOG score 0-2 points; 7. No contraindication of radiotherapy and chemotherapy; 8. No other colorectal organic diseases; 9 The patients and their families can understand the study protocol and are willing to participate in the study, and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Age<18 years; 2. Other treatments (including endoscopic resection, local anal resection, radiotherapy, chemotherapy, etc.) have been received for the above rectal lesions before enrollment; 3. The patient or family member has no strong desire to keep the anus; 4. Patients with local recurrence of rectal cancer, or with local lymph node metastasis or distant metastasis; 5. ECOG score = 3 points; 6. Patients with concurrent colorectal organic diseases; 7. Patients with familial polyposis; 8. Patients who have a history of previous colorectal surgery or pelvic radiotherapy and may affect the outcome of this treatment; 9. Pregnant or lactating women: 10. Patients with cardiovascular disease, coronary stent implantation or severe renal insufficiency who are contraindicated by radiotherapy and chemotherapy; 11. Patients or family members cannot understand the conditions and objectives of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| local recurrence rate(3 years); | — |
Secondary
| Measure | Time frame |
|---|---|
| distant metastasis rate(3 years);3-year disease-free survival;3-year overall survival;1-year and 3-year proportion of stoma;ECOG score;complication rate;severity of incontinence;quality of life; | — |
Countries
China
Contacts
Public ContactZhong Yunshi
Zhongshan Hospital of Fudan University
Outcome results
None listed