A Prospective, Multicenter Randomized Controlled Study of the Application of Preoperative FOLFOXIRI Chemotherapy Combined With Lateral Lymph Node Dissection in Low- and Medium-lying Rectal Cancer With Lateral Lymph Node Metastasis

• Status: Enrolling by invitation
• Trial end date: 2029-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trial is to compare in newly diagnosed patients with resectable rectal cancer with lateral lymph node metastasis. This study aims to

• further verify the safety and efficacy of FOLFOXIRI three-drug regimen

• Using multiple omics techniques to identify and confirm specific molecular markers Participants will be treated with FOLFOXIRI three-drug combination regimen. Researchers will compare another group treated with conventional preoperative chemoradiotherapy to see if the experimental group is superior to the control group in terms of 3-year disease free survival, local recurrence rate, lateral lymph node positivity rate, and 5-year overall survival rate.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.