Low to medium risk of stage II/III rectal cancer
Conditions
Interventions
2 cycle group:2 cycles of CAPOX chemotherapy
4 cycle group:4 cycles of CAPOX chemotherapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 75 years, no gender limitation; 2. Patients with middle risk stage II/III rectal cancer under MRI and intracavinal ultrasound, namely low rectal cancer: T3A-BN0-1M0, EMVI(±), MRF (-) (>=2mm); Middle-high rectal cancer: T3A-CN0-1M0, EMVI(±), MRF (-) (>=2mm); No more than 3 lymph nodes with short diameter over 8mm or highly suspected metastases; Patients with very low rectal cancer who met the above criteria and could achieve negative circumferential margin under ELAPE surgery could be included in the group 3. Fibrocolonoscopy or anal examination, where the lower boundary of the lesion was less than or equal to 12cm from the anal margin; 4. Rectal adenocarcinoma confirmed by pathology; 5. ECOG score: 0-1; 6. Patients with primary rectal cancer who did not receive surgery (except palliative stomy), radiotherapy, systemic chemotherapy or other anti-tumor therapy before enrollment; 7. Main organs function normally, that is, meet the following characteristics: (1) Blood routine examination criteria should meet: Hb >= 9g/dL, WBC >= 3.5/4.0x10^9/L, neutrophils >= 1.5x10^9/L, PLT >= 100x10^9/L; (2) Biochemical tests should meet the following criteria: CREA and BIL <= 1.0 times upper limit of normal (ULN), ALT and AST <= 2.5xULN, alkaline phosphatase (ALP) <= 2.5xUNL, total bilirubin (TBIL) <= 1.5xUNL; 8. Women of childbearing age must have had a pregnancy test (serum or urine) 7 days prior to enrolment, be negative, and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last dosing. For men, surgical sterilization or consent to use an appropriate method of contraception during the trial or for 8 weeks after the last dosing; 9. Subjects volunteered to participate in this study, signed the informed consent, and showed good compliance and followed up.
Exclusion criteria
Exclusion criteria: 1. Patients considered with Lynch syndrome; 2. Patients who did not consider metastasis at the initial diagnosis but actually showed distant metastasis during treatment; 3. Previous or coexisting malignancies (including concurrent colon cancer), except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 4. Breastfeeding women; 5. Patients with severe cardiovascular diseases and diabetes that is not easily controlled; 6. People with mental disorders; 7. Severe infection; 8. Patients in thrombolytic/anticoagulant therapy, bleeding quality or coagulation dysfunction; or aneurysm, stroke, transient ischemic attack, arteriovenous malformation in the past year; 9. Previous renal history, urine test found urinary protein or clinically abnormal renal function; 10. History of gastrointestinal fistula, perforation, bleeding, or severe ulcer; 11. Allergic to 5-FU or platinum; 12. The presence of serious gastrointestinal diseases that affect the absorption of oral chemotherapeutic drugs; 13. Participants in additional clinical trials within 4 weeks prior to the start of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pTRG3 proportion; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;3-years disease free survival;3-year / 5-year distant metastasis-free survival; | — |
Countries
China
Contacts
Public ContactWang Ziqiang
Department of Gastrointestinal Surgery, West China Hospital, Sichuan University
Outcome results
None listed