Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer

Phase 2

Completed

• Conditions: Locally Advanced Rectal Cancer
• Interventions: Drug: FOLFOXIRI

• Registration Number: NCT03443661
• Lead Sponsor: Aiping Zhou

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.

Study Timeline

• Study Start: 2016-02-06
• Study First Submitted: 2018-01-14
• Study First Submitted QC: 2018-02-18
• Study First Posted: 2018-02-23
• Primary Completion: 2019-03-01
• Study Completion: 2020-04-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Histologically confirmed locally advanced rectal cancer;
2. 18-70 years ；
3. Clinicalstage:T3,4a,N0,M0;T1-4a,N+,M0;
4. Tumor from anus >5cm and ≤15cm;
5. ECOG=0-1;
6. Available organ function:ALT≤1.5xULN;AST≤1.5xULN;TBIL≤1.0xULN; NEUT≥2×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;
7. Informed consent;
8. UGT1A1:UGT1A1*1/UGT1A1*1,UGT1A1*1/UGT1A1*28,UGT1A1*1/UGT1A1*6;

Exclusion Criteria

1. Clinical stage T4b or unresectable disease;
2. History of pelvic radiotherapy;
3. History of chemotherapy within 5 years;
4. History of chronic diarrhea;
5. Tumor causes intestinal obstruction, intestinal perforation, and severe bleeding;
6. Hepatitis B surface antigen positive; Hepatitis C virus infection; Cirrhosis of the liver for any cause;
7. UGT1A1:UGT1A1*28/UGT1A1*28,UGT1A1*6/UGT1A1*6;
8. Other cancers in the past 5 years, except for cervical carcinoma in situ or non-melanoma skin cancer;
9. Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; interstitial pneumonia,pulmonary fibrosis, uncontrolled diabetes, renal insufficiency;
10. Mental illness;Pregnant or lactating women;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
pCR	1 year	Pathological complete response according to Mandard tumor regression grading

Secondary Outcome Measures

Name	Time	Method
locoregional recurrence rate	1 year	locoregional recurrence rate
Safety	1 year	Including adverse events during neoadjuvant chemotherapy,surgery and perioperative complications
R0 resection rate	1 year	R0 resection rate

Trial Locations

Locations (1)

National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, China