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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

NCT06048146 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Lymph Node Metastasis
  • Cancer of Rectum and Anus
  • Oxaliplatin
  • Intestinal Neoplasms
  • Gastrointestinal Neoplasms
  • Rectal Diseases
  • Rectal Neoplasms

Interventions

DRUG

Experimental: FOLFOXIRI and Lateral lymph node dissection

Irinotecan 150mg /m2, d1, oxaliplatin 85mg/m2, d1, 5-Fu, 2400mg/m2, pumped continuously for 46 hours and repeated for 14 days

DRUG

Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissection

Radiotherapy was administered five days a week (pelvic 2 Gy/ time, GT50 Gy) for five weeks with capecitabine (1650mg/m2/ day, orally divided into two doses). Intensity modulated radiotherapy (IMRT) was used

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • jianwei liang, M.D. · Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2025-09-01
Completion
2025-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06048146 on ClinicalTrials.gov