NCT03443661

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

3.1 years

First QC Date

January 14, 2018

Last Update Submit

January 29, 2021

Conditions

Locally Advanced Rectal Cancer

Keywords

5-Fluorouracilrectal canceririnotecanoxaliplatinneoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • pCR

    Pathological complete response according to Mandard tumor regression grading

    1 year

Secondary Outcomes (3)

  • R0 resection rate

    1 year

  • locoregional recurrence rate

    1 year

  • Safety

    1 year

Study Arms (1)

FOLFOXIRI

EXPERIMENTAL

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

Drug: FOLFOXIRI

Interventions

FOLFOXIRIDRUG

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

FOLFOXIRI

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed locally advanced rectal cancer;
  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, 100021, China

Location

Related Publications (1)

  • Zhang W, Zhou H, Jiang J, Zhu Y, Zou S, Jiang L, Tang Y, Liang J, Sun Y, Jiang Z, Qu W, Li Y, Zhou A. Neoadjuvant chemotherapy with modified FOLFOXIRI for locally advanced rectal cancer to transform effectively EMVI and MRF from positive to negative: results of a long-term single center phase 2 clinical trial. BMC Cancer. 2023 Jun 27;23(1):592. doi: 10.1186/s12885-023-11103-x.

    PMID: 37370032DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

FOLFOXIRI protocol

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Aiping Zhou, Doctor

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
UNKNOWN
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

January 14, 2018

First Posted

February 23, 2018

Study Start

February 6, 2016

Primary Completion

March 1, 2019

Study Completion

April 1, 2020

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

CN(1)