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Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer

Primary Purpose

Locally Advanced Rectal Cancer

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

FOLFOXIRI

About this trial

This is an interventional treatment trial for Locally Advanced Rectal Cancer focused on measuring 5-Fluorouracil, rectal cancer, irinotecan, oxaliplatin, neoadjuvant chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FOLFOXIRI

Arm Description

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

Outcomes

Primary Outcome Measures

pCR

Pathological complete response according to Mandard tumor regression grading

Secondary Outcome Measures

R0 resection rate

locoregional recurrence rate

Safety

Including adverse events during neoadjuvant chemotherapy,surgery and perioperative complications

Full Information

NCT ID

NCT03443661

First Posted

January 14, 2018

Last Updated

January 29, 2021

Sponsor

Aiping Zhou

1. Study Identification

Unique Protocol Identification Number

NCT03443661

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 Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

February 6, 2016 (Actual)

Primary Completion Date

March 1, 2019 (Actual)

Study Completion Date

April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Aiping Zhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Rectal Cancer

Keywords

5-Fluorouracil, rectal cancer, irinotecan, oxaliplatin, neoadjuvant chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FOLFOXIRI

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

FOLFOXIRI

Intervention Description

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

Primary Outcome Measure Information:

Title

pCR

Description

Pathological complete response according to Mandard tumor regression grading

Time Frame

1 year

Secondary Outcome Measure Information:

Title

R0 resection rate

Description

R0 resection rate

Time Frame

1 year

Title

locoregional recurrence rate

Description

locoregional recurrence rate

Time Frame

1 year

Title

Safety

Description

Including adverse events during neoadjuvant chemotherapy,surgery and perioperative complications

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aiping Zhou, Doctor

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College

City

Beijing

ZIP/Postal Code

100021

Country

China

12. IPD Sharing Statement

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Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer

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