A Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

255

Participants

Timeline

Start Date

August 15, 2020

Primary Completion Date

July 12, 2022

Study Completion Date

June 1, 2025

Conditions
Rectal Cancer
Interventions
COMBINATION_PRODUCT

Concurrent Chemoradiotherapy

"Radiotherapy:~50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.~Concurrent chemotherapy:~Capecitabine 1650 mg/m2/d"

DRUG

XELOX

"Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 6 cycles.~6 courses,3 weeks per course"

DRUG

mFOLFOX

Administration of l-LV (400 mg/m2) and oxaliplatin (85 mg/ m2) by intravenous infusion over 2 h, followed by rapid intravenous infusion (iv) of 5-FU (400 mg/m2) and then slow infusion (civ) of 5-FU (2400 mg/m2 over 46 h), is repeated every 2 weeks for 9 cycles.

PROCEDURE

TME

Total mesorectal excision

Trial Locations (1)

100021

Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing

All Listed Sponsors
collaborator

Peking University Cancer Hospital & Institute

OTHER

collaborator

Peking Union Medical College Hospital

OTHER

collaborator

Jilin Provincial Tumor Hospital

OTHER

collaborator

Cancer Hospital of Guizhou Province

OTHER

collaborator

Xijing Hospital

OTHER

lead

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER