NCT03698253

Brief Summary

The survey is a retrospective study to evaluate the prognotic value of EGFR expression, KRAS mutations and tumor sideness in patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable colorectal-cancer

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

October 1, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

4.7 years

First QC Date

October 1, 2018

Last Update Submit

October 4, 2018

Conditions

Colorectal Cancer

Keywords

EGFRKRAStumor sidenessFOLFIRIregorafenibmetastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    Time from treatment to disease progresses

    From date of initiaton of treatment until the date of first documented progression, assessed up to 23 months

Secondary Outcomes (4)

  • Overall survival

    From date of initiation of treatment until the date of death from any cause, assessed up to 23 months

  • Best objective response

    From date of initiation of treatment until the date of disease progression, assessed up to 23 months

  • Disease control rate

    From date of initiation of treatment until the date of disease progression, assessed up to 23 months

  • Rate of treatment-associated adverse events.

    Adverse events is evaluated and recorded during every cycle of treatment. Up to 23 months.

Study Arms (1)

Regorafenib plus FOLFIRI

EXPERIMENTAL

Regimen for treatment consists of irinotecan (180 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA6/TA6) and UGT1A1 genotyping (TA6/TA7); 120 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA7/TA7)), followedby Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks. After every 2 cycles of each different dose of irinotecan, if adverse events (AEs) are under the grade 2, we will escalate the dose of 30 mg/m2. The estimated maximal dose of irinotecan is 260 mg/m2 for UGT1A1 genotyping (TA6/TA6); 240 mg/m2 for UGT1A1 genotyping (TA6/TA7); 180 mg/m2 for UGT1A1 genotyping (TA7/TA7). Regorafenib is administered at adjusted doseage of 120 mg daily for 3 weeks in a 4-week cycle.

Drug: RegorafenibGenetic: UGT1A1 genotyping (TA6/TA6)Genetic: UGT1A1 genotyping (TA6/TA7)Genetic: UGT1A1 genotyping (TA7/TA7)

Interventions

RegorafenibDRUG

Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle

Also known as: stivarga
Regorafenib plus FOLFIRI
UGT1A1 genotyping (TA6/TA6)GENETIC

The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2

Regorafenib plus FOLFIRI
UGT1A1 genotyping (TA6/TA7)GENETIC

The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2

Regorafenib plus FOLFIRI
UGT1A1 genotyping (TA7/TA7)GENETIC

The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2

Regorafenib plus FOLFIRI

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 20-85 years old
  • Histologically proven metastatic colorectal cancer (mCRC).
  • Patients with progressing mCRC who were previously treated with FOLFOX, FOLFIRI, anti-VGFR monoclonal antibody (MoAb), and anti-EGFR MoAb if KRAS-wild-type tumors were identified.
  • Patient was able to understand the requirements of the study and written informed consent was obtained from each subject.

You may not qualify if:

  • Patients who do not meet the including criteria or unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jaw-Yuan Wang, PhD

    Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Vice Superintendent

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 5, 2018

Study Start

October 1, 2013

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

October 5, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)