Spots Global Cancer Trial Database for Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer

Official Title: A Pilot Phase II Study of Neoadjuvant Triplet Chemotherapy Regimen （FOLFOXIRI） in Patients With Locally Advanced Rectal Cancer

Study ID: NCT03443661

Conditions

Locally Advanced Rectal Cancer

Interventions

FOLFOXIRI

Study Description

Brief Summary: This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced rectal cancer

Detailed Description: In this pilot phase II study, the investigators enrolled Chinese adults(age 18 to 70 years) with locally advanced stage II/III rectal cancer. The neuadjuvant chemotherapy regimen is : oxaliplatin 85 mg/m2 and irinotecan 150 mg/m2, combined with 5FU 2,400 mg/m2 by 46 h infusion, repeated at 2week intervals for 5 cycles. Total mesorectal excision was scheduled 4-5 weeks after completion of neoadjuvant treatment and followed by a further 7 cycles of mFOLFOX or 4 cycles of XELOX. Primary outcome measures of this phase II trial were feasibility, safety, tolerance and efficacy of neoadjuvant treatment.