Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation

This is an interventional treatment trial for Rectal Cancer Read More

Inclusion Criteria:

• 1）Age: 18 to 75 years old;
• 2）Histological diagnosis of rectal adenocarcinoma;
• 3）Distance form anal margin ≤ 5cm: cT3-4aN + M0, there is no distant metastasis, lymph node positive, or the tumor breaking through the muscular layer, no invasion of the adjacent organs , positive MRF, it is estimated that R0 resection can be performed;
• 4）From the anal margin>5cm: cT3c-4aN+M0, there is no distant metastasis, lymph node positive, or the tumor breaking through the muscular layer with invading the mesorectum more than 5mm, no invasion of the adjacent organs, positive MRF, it is estimated that R0 resection can be performed;
• 5）Preoperative staging method: All patients undergoing anal examination, high-resolution MRI and/or EUS for preoperative staging. The diameter of parenteral lymph node ≥10mm, lymph node shape or the MRI characteristics is consistent with typical lymph node metastasis. If combined with EUS, the material should be submitted to the central assessment team for judgment when there is a contradiction in the staging method. Preoperative chest and abdomen CT, pelvic MRI are used for excluding distant metastasis;
• 6）Confirmed as the lower edge of tumor is located within 12 cm from the anal margin by MRI examination
• 7）There is no signs of intestinal obstruction, or obstruction of intestinal after treating with proximal colostomy has been relieved;
• 8）Patients did not previously receive rectal surgery, chemotherapy or radiation therapy , biological treatment , except for endocrine therapy;
• 9）ECOG Performance Status :0-1
• 10）Life expectancy: more than 2 years;
• 11）Laboratory values：Hematology: white blood cell count>4000/mm3; Platelet count>100000/mm3; Hemoglobin >10g/dL; Liver function: SGOT and SGPT < 1.5 upper limit of normal(ULN); Bilirubin< 1.5mg/dL; Renal function :Creatinine <1.8mg/dL.

Exclusion Criteria:

• 1）Tumor invasion of surrounding tissue organs (T4b) by preoperative staging assessment;
• 2）Obturator lymph node metastasis;
• 3）Arrhythmia requires treatment with antiarrhythmia (except for beta-blockers or digoxin), symptomatic coronary artery disease, myocardial ischemia (myocardial infarction within the last 6 months) or congestive heart failure exceeding NYHA class II;
• 4）Severe hypertension with poor control;
• 5）History of HIV infection or active phase of chronic hepatitis B or C infection with high copy viral DNA;
• 6）Other active serious infections according to NCI-CTC version 4.0;
• 7）There is preoperative evidence for distant metastasis outside pelvis;
• 8）Cachexia and organ function decompensation
• 9）History of pelvic or abdominal radiotherapy;
• 10）Multiple primary cancer;
• 11）Patients with epilepcy requiring treatment ( steroids or antiepileptic treatment);
• 12）History of other malignant tumors within 5 years, except for cured cervical carcinoma in situ or skin basal cell carcinoma;
• 13）Drug abuse and medical, psychological or social conditions interfering patient participation in research or the evaluation of research results;
• 14）Any allergy to clinical research drugs or any drugs associated with this study;
• 15）Any unstable condition or condition that may endanger safety and compliance of patients;
• 16）Pregnancy or the lactating female without adequate contraception.