Rectal cancer
Conditions
Interventions
Group 2 cycle:2 cycles capox neoadjuvant chemotherapy
Group 4 cycle:4 cycles capox neoadjuvant chemotherapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old; No gender limitation; 2. Patients with moderate risk stage II/III rectal cancer by MRI and intravenal ultrasound, namely low rectal cancer: T3A-BN0-1M0, EMVI (±), MRF (-) (>= 2mm); Middle and high rectal cancer: T3A-CN0-1m0, EMVI (±), MRF (-) (>= 2mm); There were no more than 3 lymph nodes with short diameter of more than 8mm or highly suspected metastasis. Patients with very low rectal cancer who met the above criteria and could achieve negative circumferential resection margin under ELAPE surgery could be included in the group. 3. Fibrocolonoscopy or anal examination showed that the lower boundary of the lesion was less than = 12cm from the anal margin; 4. No distant metastasis has been confirmed by comprehensive examination; 5. Rectal adenocarcinoma confirmed by pathology; 6. ECOG score: 0-1; 7. Patients with primary rectal cancer who had not received surgery (except palliative stomy), radiotherapy, systemic chemotherapy or other anti-tumor therapy before enrollment; 8. Normal function of major organs means that the following characteristics are met: (1) Blood routine examination standards should meet: HB >= 9g/dL, WBC >= 3.5/4.0x10^9/L, neutrophil >= 1.5x10^9/L, PLT >= 100x10^9/L; (2) Biochemical tests should meet the following standards: Crea and BIL <= 1.0 times the upper limit of normal value (ULN), ALT and AST <= 2.5 times the upper limit of normal value (ULN), alkaline phosphatase (ALP) <= 2.5xUNL, total bilirubin (Tbil) <= 1.5xUNL; 9. No history of platinum drug allergy when there is no 5-FU drug allergy; 10. Women of reproductive age must undergo a pregnancy test (serum or urine) 7 days prior to enrollment with a negative result and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last dose. For men, use surgical sterilization or consent to use an appropriate method of contraception during the trial or 8 weeks after the last dose; 11. Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with Lynch syndrome; 2. Patients who did not consider metastasis at initial diagnosis and were proved to have distant metastasis during treatment; 3. Previous or concurrent malignancy (including concurrent colon cancer), except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 4. Pregnant or nursing women; 5. Patients with serious cardiovascular diseases and diabetes that is difficult to control; 6. People with mental disorders; 7. Seriously infected persons; 8. The patient is in thrombolytic/anticoagulant treatment and has bleeding quality or coagulation dysfunction; Aneurysm, stroke, TRANSIENT ischemic attack, arteriovenous malformation in the past year; 9. Previous renal history, urine test found significant abnormality of urinary protein or clinical renal function; 10. History of gastrointestinal fistula, perforation, bleeding, or severe ulceration; 11. Serious gastrointestinal diseases affecting oral chemotherapy drug absorption; 12. Enrolled in an additional clinical trial within 4 weeks prior to the start of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Tumor Regression Grade; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival rate;Disease free survival; | — |
Countries
China
Contacts
Public ContactWang Ziqiang
West China Hospital, Sichuan University
Outcome results
None listed