locally advanced rectal cancer
Conditions
Interventions
Case series:Preoperative neoadjuvant chemoradiotherapy combined with total mesotomy and postoperative adjuvant chemotherapy
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Preoperative endoscopic pathological biopsy confirmed rectal cancer, and the lower margin of the tumor was less than 12cm from the anal margin; 2) No gender restriction; Aged 18 to 75 years old, BMI <=32 kg/m2; 3) Patients with non-local recurrence and distant metastasis; 4) No multiple colorectal cancer; 5) Stage II/III was diagnosed by MRI or rectal ultrasonography; 6) After joint diagnostic evaluation by multidisciplinary teams of surgery, imaging, chemotherapy and radiotherapy; 7) Patients and their family members can understand and are willing to participate in this study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients who have a history of malignant colorectal tumor or have been diagnosed as malignant tumors in other areas within the last 5 years; 2) Patients with intestinal obstruction, intestinal perforation, intestinal bleeding and other conditions requiring emergency surgery; 3) The tumor invades the external sphincter and levator ANI muscle or involves the adjacent organs and needs to be removed together with the internal organs; 4) Having a history of inflammatory bowel disease (IBD) or familial adenomatous Polyposis (FAP); 5) Recently diagnosed with other malignant tumors; 6) Patients who had participated in or were participating in other clinical trials within the previous 4 weeks were included; 7) ASA grade >=IV and/or ECOG Physical Status score >=2; 8) Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or patients with severe underlying diseases who cannot tolerate surgery; 9) A history of serious mental illness; 10) Pregnant or lactating women; 11) Patients with uncontrolled infection before operation; 12) Patients with other clinical or laboratory conditions considered by the researcher should not participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median disease-free survival;median disease-free survival;3-year disease-free survival rate;3-year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical resection quality;Perioperative conditions;Postoperative function;Quality of life;Safety and efficacy of chemoradiotherapy;Postoperative pathology;Cost-benefit analysis; | — |
Countries
China
Contacts
Public ContactDongWang Yan
Shanghai General Hospital
Outcome results
None listed