NCT06048146View on ClinicalTrials.gov

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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

October 1, 2022

Primary Completion Date

September 1, 2027

Study Completion Date

September 1, 2029

Conditions
Lymph Node MetastasisCancer of Rectum and AnusOxaliplatinIntestinal NeoplasmsGastrointestinal NeoplasmsRectal DiseasesRectal 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

Trial Locations (1)

100021

Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing

All Listed Sponsors
lead

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER