Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Locally Advanced Rectal Cancer

Intervention / Treatment
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* Drug: FOLFOXIRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed locally advanced rectal cancer; 18-70 years ； Clinicalstage:T3,4a,N0,M0;T1-4a,N+,M0; Tumor from anus >5cm and ≤15cm; ECOG=0-1; 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; Informed consent; UGT1A1:UGT1A1*1/UGT1A1*1,UGT1A1*1/UGT1A1*28,UGT1A1*1/UGT1A1*6; Exclusion Criteria: Clinical stage T4b or unresectable disease; History of pelvic radiotherapy; History of chemotherapy within 5 years; History of chronic diarrhea; Tumor causes intestinal obstruction, intestinal perforation, and severe bleeding; Hepatitis B surface antigen positive; Hepatitis C virus infection; Cirrhosis of the liver for any cause; UGT1A1:UGT1A1*28/UGT1A1*28,UGT1A1*6/UGT1A1*6; Other cancers in the past 5 years, except for cervical carcinoma in situ or non-melanoma skin cancer; Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; interstitial pneumonia,pulmonary fibrosis, uncontrolled diabetes, renal insufficiency; Mental illness;Pregnant or lactating women;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOLFOXIRI<br>oxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals | Drug: FOLFOXIRI<br>* oxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pCR | Pathological complete response according to Mandard tumor regression grading | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate | R0 resection rate | 1 year | 
| locoregional recurrence rate | locoregional recurrence rate | 1 year | 
| Safety | Including adverse events during neoadjuvant chemotherapy,surgery and perioperative complications | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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5-Fluorouracil, rectal cancer, irinotecan, oxaliplatin, neoadjuvant chemotherapy