NCT03443661

Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Aiping Zhou · Unknown
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
DRUG	FOLFOXIRI	oxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals

Timeline

• Start date: 2016-02-06
• Primary completion: 2019-03-01
• Completion: 2020-04-01
• First posted: 2018-02-23
• Last updated: 2021-02-01

Locations

1 site across 1 country: China