Rectal Cancer
Conditions
Interventions
simultaneous boost intensity-modulated radiotherapy(SIB-IMRT):N/A
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male or female; 2. ECOG level 0-1; 3. Pathological diagnostic criteria: histopathological and/or cytology diagnosis of rectal adenocarcinoma; 4. Clinical diagnostic criteria: baseline rectal MRI confirmed clinical stage T3-T4 or any T stage and N+ (eighth edition of AJCC staging system) and baseline examination showed no distant metastases; 5. Diagnostic criteria for clinically positive lateral lymph nodes: swollen lymph nodes located in the iliac or obturator lymphatic drainage area can be seen on baseline rectal MRI, with a short diameter of = 7mm, and irregular lymph node margins or uneven signals; The number of positive lateral lymph nodes = 3, the lateral lymph nodes did not invade peripheral blood vessels, and the short diameter of the positive lateral lymph nodes was = 20mm; 6. Digital examination or colonoscopy to determine that the lower boundary of the tumor is 8cm from the margin =; 7. No other serious medical comorbidities; 8. Conscious and can cooperate with positioning, positioning and treatment; 9. The design of the intensity-modulated radiotherapy plan meets the dosimetric requirements; 10. Subjects voluntarily join the study, sign informed consent, have good compliance, and are willing to accept follow-up; 11. Plan radical rectal cancer surgery in our hospital; 12. No history of pelvic radiotherapy; 13. Important organs or functions meet the following requirements (no blood components, cell growth factors are allowed to be corrected within 2 weeks before the date of examination): can control defecation and urination on their own to facilitate radiotherapy preparation; Absolute neutrophil count (ANC) = 1.5×109/L, platelet =100×109/L, hemoglobin =10g/dL; serum albumin = 3.0 g/dL, total bilirubin= ULN (upper reference value), ALT, AST, and/or AKP =2.5 × ULN, serum creatinine =ULN; International normalized ratio (INR) and activated partial thromboplastin time (APTT) =ULN; 13. Women of childbearing age must have a negative serum hCG test within 7 days prior to enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of chemoradiotherapy; For men, surgical sterilization or consent to appropriate methods of contraception during observation and up to 8 weeks after the last chemoradiotherapy administration should be agreed.
Exclusion criteria
Exclusion criteria: 1. ECOG=2, or KPS score less than or equal to 70 points; 2. Age> 75 years old; 3. Distant transfers; 4. Previous or simultaneous malignant diseases, except for well-treated tumors with excellent prognosis such as basal cell carcinoma of the skin, early thyroid cancer, breast cancer, and lymphoma; 5. Known allergy to capecitabine or oxaliplatin; 6. Recurrent rectal cancer; 7. Uncontrollable medical conditions: history of cardiac disease: New York Cardiac Function Grade (NYHA) greater than 2, active coronary heart disease, arrhythmia requiring drug therapy or refractory hypertension lasting more than 12 months; Current active infection (NCI-CTCAE 5.0 with greater than 2nd degree); myocardial infarction, stroke, or psychosis within 6 months. 8. Emergency surgery is required due to intestinal obstruction, perforation, bleeding, etc.; 9. Gastrointestinal diseases that can cause capecitabine malabsorption: such as short bowel syndrome, inflammatory bowel disease, etc.; 10. Accompanied by unresectable concurrent intestinal diseases; 11. Survival prediction is less than 3 months; 12. Those who cannot undergo MRI examination due to contraindications or relative contraindications to MRI examination; 13. Breastfeeding or pregnant women in the reproductive period who do not have adequate contraception; 14. Psychiatric or medical factors make it impossible for the patient to know; 15. Those who are judged by the investigator to have poor compliance or are not suitable for this clinical trial; 16. Receiving anti-tumor therapy before screening; 17. Current or pre-enrollment participation in other interventional clinical trials; 18. Have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation; 19. Active hepatitis B (HbsAg positive and HBV-DNA =2500 copy number/ml or 500IU/ml) or hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower limit of the assay); Hepatitis B and C infection (positive for HbsAg or HbcAb and positive for HCV antibodies).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Regrowth Rate of LPLN; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress Free Survival;distant metastases;Local Regional Free Survival; | — |
Countries
China
Contacts
Public ContactWang Weihu
Beijing Cancer Hospital
Outcome results
None listed