NCT03329183

Brief Summary

This trial aims to evaluate the efficacy, safety of high-dose FOLFIRI regimen in advanced colorectal cancer patients with wild-type UGT1A1\*6 and \*28.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 25, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

Same day

First QC Date

October 25, 2017

Last Update Submit

February 14, 2019

Conditions

Colorectal Cancer

Keywords

IrinotecanUGT1A1Advanced Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate(ORR)

    Evaluation of tumor burden based on RECIST criteria every 4 cycles(each cycle is 14 days), ORR is the proportion of patients with reduction in tumor burden of a predefined amount, including complete response and partial response.

    up to 55 months

Secondary Outcomes (2)

  • Early tumor shrinkage (ETS) rate

    up to 55 months

  • Disease Control Rate (DCR)

    up to 55 months

Study Arms (3)

HD-FOLFIRI

EXPERIMENTAL

Advanced CRC patients with Wild-type UGT1A1\*6 and \*28 receive high-dose FOLFIRI regimen (Irinotecan 260mg/m2 2h, leucovorin 400mg/m2, 5- fluorouracil 400mg/m2 , 5- fluorouracil 2400 mg/m2 46h, 14 days per course.)

Drug: Irinotecan

SD-FOLFIRI

NO INTERVENTION

Advanced CRC patients with Wild-type UGT1A1\*6 and \*28 receive standard-dose FOLFIRI regimen (Irinotecan 180mg/m2 2h, leucovorin 400mg/m2, 5- fluorouracil 400mg/m2 , 5- fluorouracil 2400 mg/m2 46h, 14 days per course)

SD-FOLFOX-6

NO INTERVENTION

Advanced CRC patients with Wild-type UGT1A1\*6 and \*28 receive standard-dose FOLFOX-6 regimen (Oxaliplatin 130mg/m2 2h, leucovorin 400mg/m2, 5- fluorouracil 400mg/m2 , 5- fluorouracil 2400 mg/m2 46h, 14 days per course)

Interventions

IrinotecanDRUG

High-dose FOLFIRI regimen (Irinotecan 260mg/m2 2h, leucovorin 400mg/m2, 5- fluorouracil 400mg/m2 , 5- fluorouracil 2400 mg/m2 46h, 14 days per course)

Also known as: CPT-11
HD-FOLFIRI

Eligibility Criteria

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

You may qualify if:

  • Patients should be histologically diagnosed with advanced colorectal adenocarcinoma or postoperative recurrence
  • Patients should be with UGT1A1\*28 wild-type TA6/6 and UGT1A1\*6 wild-type G/G
  • Patients have measurable lesions
  • Patients are not available for targeted therapy or patients refuse to receive targeted therapy
  • Age should be more than 18 years
  • Performance status should be 0-2
  • Hemoglobin should be more than 9.0 g/dL; Absolute Neutrophil Count should be more than 1,500/mm3; Platelet should be more than 80,000/mm3；Total Bilirubin should be less than 1.5 times of the upper limit of normal value; Alanine aminotransferase and Glutamic-oxaloacetic transaminase should less than 2.5 times of the upper limit of normal value (it can be 5 times if liver metastasis); Creatinine should be be less than 1.5 times of the upper limit of normal value

You may not qualify if:

  • Patients with UGT1A1\*28 wild-type TA6/7, TA7/7 and UGT1A1\*6 wild-type G/A,A/A;
  • Patients with brain metastases;
  • Patients could not tolerate chemotherapy;
  • Patients have secondary primary tumor;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Yuan-Sheng Zang, Prof

    Shanghai Changzheng Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan-Sheng Zang, Prof

CONTACT

+8613816584620doctorzangys@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor/Associate chief physician

Study Record Dates

First Submitted

October 25, 2017

First Posted

November 1, 2017

Study Start

March 1, 2019

Primary Completion

March 1, 2019

Study Completion

March 1, 2022

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

CN(1)