Preoperative FOLFOXIRI Chemotherapy Combined With Lateral Lymph Node Dissection in Rectal Cancer
Lymph Node Metastasis, Cancer of Rectum and Anus, Oxaliplatin
About this trial
This is an interventional treatment trial for Lymph Node Metastasis
Eligibility Criteria
Inclusion Criteria: Age 18-70 years old, gender is not limited; The clinical stage based on magnetic resonance imaging (MRI) is cT1-4aN+M0 (according to AJCC Cancer Staging Manual, 8th Edition, 2018). Meet the criteria for lateral lymph node metastasis (lymph node short diameter ≥7mm, or lymph node short diameter ≥5cm with uneven internal signals and no chemical shift effect, or irregular boundaries); The primary tumor was located in the rectum (hard tube proctoscopy indicated that the lower margin of the lesion was less than 10cm from the anus); Kastler score ≥70, ECOG score 0 or 1; Meet the following laboratory diagnostic indicators: hemoglobin ≥100g/L, white blood cells ≥3.5×109 /L, neutrophil ≥1.5×109/L, platelet ≥100×109/L; Creatinine ≤1.5× upper limit of normal (UNL); Urea nitrogen (BUN) ≤1.5 upper limit of normal (UNL) alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5×UNL, alkaline phosphatase (ALP) ≤2.5×UNL, total bilirubin (Tbil) ≤2.5×UNL; Urinary protein (-); Clotting time is normal. Patients with primary locally advanced rectal cancer required that they had not received surgery, radiotherapy, chemotherapy or other antitumor therapy from diagnosis to enrollment; No previous pelvic radiation; Subjects voluntarily join the study and sign the informed consent. Exclusion Criteria: A history of malignancy at other sites, excluding curable non-melanic skin cancer and carcinoma in situ of the cervix; Unable to complete MRI; Preoperative examination indicated the need for combined organ resection; Allergic to 5-Fu and platinum drugs; Inability to swallow oral medications; The patient is under thrombolytic or anticoagulant therapy, has bleeding diathesis or coagulation dysfunction, or has occurred in the past year Aneurysm, stroke, transient ischemic attack, arteriovenous malformation; After renal history, urine test found proteinuria or clinical renal function was obviously abnormal; History of digestive tract fistula, perforation or severe ulcer; Active infection is present; Clinically significant cardiac disease (e.g., uncontrolled hypertension (160/110) mm Hg blood pressure, any history of myocardial infarction, unstable angina), NYHA class Ⅱ congestive heart failure, unstable symptomatic arrhythmias, or class II peripheral vascular disease. Myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment; Participating in other clinical trials currently or within 4 weeks prior to enrollment; long-term adverse drug history, drug addiction history of mental disorders; Other cases where the examiner considers from the registration study that there are good reasons for non-conformity: if there are potential inconsistencies with the clinical protocol.
Sites / Locations
- Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
FOLFOXIRI and Lateral lymph node dissection
Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissection
Participants will receive three cycles of chemotherapy with FOLFOXIRI regimen, and the specific dose was: irinotecan 150mg/m2, d1, Oxaliplatin 85mg/m2, d1, 5-Fu, 2400mg/m2, continuously pumped for 46 hours, repeated for 14 days. After 3 cycles of chemotherapy, rectal MRI reexamination was performed, and the efficacy was evaluated using the RECIST method. For cCR or cPR, another 2 cycles of chemotherapy will be performed, and CT and rectal MRI evaluations will be performed again after treatment. Radical rectal cancer surgery and LLND were performed 4-6 weeks after the last administration (unilateral or bilateral LLND was determined based on the metastasis of LLN before treatment).
All patients received preoperative long-term concurrent chemoradiotherapy: radiotherapy for five weeks, five days a week (pelvic 2 Gy/ time, GT50 Gy), during which capecitabine (1650mg/m2/ day, orally divided twice). Intensity modulated radiotherapy was used. CT and rectal MRI were evaluated again 8-12 weeks after radiotherapy, followed by radical resection of rectal cancer plus LLND (unilateral or bilateral LLND was performed according to LLN metastasis before treatment).