Rectal cancer
Conditions
Interventions
Observation group:None
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 75 years old, regardless of gender; 2. ECOG level 0-1; 3. Pathological diagnostic criteria: Pathological and/or cytological examination diagnosed as rectal adenocarcinoma, with immunohistochemistry or molecular testing confirming proficient mismatch repair (pMMR) or microsatellite stable (MSS) status; 4. Clinical diagnostic criteria: Baseline rectal MRI confirmed a clinical stage of T3-T4 or any T stage and N+(8th edition AJCC staging system), and baseline examination showed no distant metastasis; 5. Determine the distance between the lower edge of the tumor and the anal verge by DRE or colonoscopy, which is = 5cm; 6. No other serious internal medicine complications; 7. Conscious and able to cooperate with positioning and treatment; 8. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and were willing to undergo follow-up; 9. No history of pelvic radiation therapy; 10. Important organs or functions meet the following requirements (no blood components or cell growth factors are allowed to be used for correction within 2 weeks before the examination date): (1)Able to autonomously control defecation and urination to facilitate radiotherapy preparation work; (2)Absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelet >= 100 × 10^9/L, hemoglobin >=10g/dL; (3)Serum albumin >= 3.0 g/dL, total bilirubin <= ULN (upper limit of reference value), ALT, AST, and/or AKP <=2.5 × ULN, serum creatinine <= ULN; (4)International standardized ratio (INR) and activated partial thromboplastin time (APTT) = ULN; 11. Women of childbearing age must undergo a negative serum HCG test within 7 days before enrollment, and voluntarily use appropriate methods of contraception during observation and within 8 weeks after the last dose of radiation and chemotherapy; For males, surgical sterilization or agreement to use appropriate methods of contraception during observation and within 8 weeks after the last dose of radiation and chemotherapy should be considered.
Exclusion criteria
Exclusion criteria: 1. ECOG >=2, or KPS score less than or equal to 70 points; 2. Age>75 years old; 3. Distant metastasis; 4. Previous or concurrent malignant diseases, excluding fully treated skin basal cell carcinoma, early thyroid carcinoma, breast cancer and other tumors with excellent prognosis; 5. Known allergies to capecitabine; 6. Recurrent rectal cancer; 7. Uncontrolled internal medicine situation: Currently, there is active infection (NCI-CTCAE 5.0 with a degree greater than 2); Clinically evident heart disease; Congestive heart failure with a New York Heart Association (NYHA) rating of >= II; Unstable symptomatic arrhythmia or >= Grade II peripheral vascular disease; Myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment 8. Emergency surgery is required due to intestinal obstruction, perforation, bleeding, etc; 9. Gastrointestinal diseases associated with impaired absorption of capecitabine, such as short bowel syndrome, inflammatory bowel disease, etc; 10. Accompanying non resectable simultaneous intestinal diseases; 11. Survival prediction of less than 3 months; 12. Those who are unable to undergo MRI examination due to contraindications or relative contraindications to MRI examination; 13. Women who are breastfeeding or pregnant during the reproductive period and do not have sufficient contraception; 14. Mental or internal factors prevent patients from being informed; 15. Researchers determine that compliance is poor or unsuitable for conducting this clinical trial; 16. Receive anti-tumor treatment before screening; 17. Participate in other interventional clinical trials currently or before enrollment; 18. Have a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; 19. Active hepatitis B (HbsAg positive, and HBV-DNA >= 2500 copies/ml or 500IU/ml) or hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analytical method); Complicated with hepatitis B and hepatitis C infection (HbsAg or HbcAb positive and HCV antibody positive);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year-distant relapse-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 year-non-regrowth disease free survival;3 year-overall survival;3 year-local recurrence-free survival;3 year-distant metastasis rate;3 year-local recurrence rate; | — |
Countries
China
Contacts
Public ContactWeihu Wang
Beijing Cancer Hospital
Outcome results
None listed