Rectal cancer
Conditions
Interventions
Case series:Combination therapy + surgery
Sponsors
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) aged 18-70 years; (2) the clinical stage based on MRI was ct1-4an +M0 (according to the 7th edition of AJCC cancer staging manual in 2010); (3) meet the criteria of lateral lymph node metastasis (short diameter of lymph node >=10mm, or short diameter of lymph node >=7cm); (4) colorectal adenocarcinoma confirmed by histopathology or reviewed by tumor hospital of Chinese academy of medical sciences; (5) the primary tumor was located in the rectum (dura proctoscopy indicated that the lower margin of the lesion was =70, ECOG score 0 or 1; (7) meet the following laboratory diagnostic indicators: Hemoglobin >=100g/L, leukocyte >=3.5x10^9/L; Neutrophil >=1.5x10^9/L, platelet >=100x10^9/L; Creatinine <=1.5 UNL; BUN <=1.5 UNL; Alanine aminotransferase (ALT), aspartic aminotransferase (AST) <=2.5 UNL; Alkaline phosphatase (ALP) <=2.5 UNL, total bilirubin (Tbil) <=2.5 UNL; Urine protein (-); Clotting time is normal; (8) patients with primary locally advanced rectal cancer were required to undergo no surgery, radiotherapy, chemotherapy or other anti-tumor treatment from diagnosis to inclusion.No previous pelvic radiation exposure; (9) subjects voluntarily join the study and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) a history of malignancies elsewhere, excluding curable non-melanin skin cancer and cervical carcinoma in situ; (2) unable to complete MRI; (3) preoperative examination indicated the need for combined visceral resection; (4) allergic to 5-fu and platinum drugs;Inability to swallow oral medicines; (5) the patient was undergoing thrombolytic and anticoagulant therapy, had bleeding quality or coagulation dysfunction, or had aneurysms, stroke, transient ischemic attack, arteriovenous malformations in the past year; (6) followed by a history of renal disease, proteinuria or clinical renal function was found to be significantly abnormal by urine examination; (7) a history of gastrointestinal fistula, perforation or severe ulcer; (8) active infection is present;Clinically apparent heart disease (e.g., medical uncontrolled hypertension (160/110) MMHG blood pressure, any history of myocardial infarction and unstable angina), New York heart association (NYHA) of ? level or congestive heart failure, unstable symptomatic arrhythmia or peripheral vascular disease of class II or higher.Myocardial infarction and cerebrovascular accidents occurred within 6 months before enrollment; (9) participate in other clinical trials at present or within 4 weeks before enrollment; (10) patients with mental disorders with a long history of adverse drug use or drug addiction; (11) other examiners, from the registration study, concluded that there were sufficient grounds for nonconformity: if there were potential inconsistencies with the clinical protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival rate; | — |
Countries
China
Contacts
Public ContactLiang jianwei
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed