NCT03031444

Brief Summary

This study was designed to analyze the prognosis and recurrence predictive factors of high risk patients (Clinical Risk Score≥3) of resectable colorectal liver metastasis. The efficacy of perioperative chemotherapy plus cetuximab and chemotherapy alone was compared for these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

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

January 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

5 years

First QC Date

December 4, 2016

Last Update Submit

January 29, 2021

Conditions

Colorectal Cancer Stage IVMetastasis

Keywords

colorectal liver metastasispreoperativechemotherapytargeted therapy

Outcome Measures

Primary Outcomes (1)

  • disease free survival

    months the patient lived from the date of liver resection to the date of disease recurrence or metastasis

    From date of hepatectomy until the date of first documented recurrence or metastasis or date of death from any cause, whichever came first, assessed up to 60 months

Secondary Outcomes (2)

  • overall survival

    From date of hepatectomy until the date of first documented death from any cause or the last follow-up if no death happened, assessed up to 60 months

  • objective response rate

    from the date of the first chemotherapy until the date two weeks after the completion of the last preoperative chemotherapy, assessed up to 6 weeks

Study Arms (2)

chemotherapy plus cetuximab

ACTIVE COMPARATOR

Cetuximab plus FOLFIRI/FOLFOX:FOLFIRI plus cetuximab \[Irinotecan 180 mg/m2 IV over 30-90 minutes, day 1;Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion, day 1;5-fluoruracil(5-FU) 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion.Repeat every 2 weeks.Cetuximab 500 mg/m2 IV over 2 hours, day 1, every 2 weeks\] or FOLFOX plus Cetuximab \[Oxaliplatin 85 mg/m2 IV over 2 hours, day 1 Leucovorin 400 mg/m2 IV over 2 hours, day 1 5-FU 400 mg/m2 IV bolus on day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks;Cetuximab 500 mg/m2 IV over 2 hours, day 1, every 2 weeks\]

Drug: Cetuximab plus FOLFIRI/FOLFOX

perioperative chemotherapy alone

ACTIVE COMPARATOR

FOLFIRI/FOLFOX/CapeOX:routine perioperative chemotherapy including FOLFIRI\[Irinotecan 180 mg/m2 IV over 30-90 minutes, day 1 Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion, day 1 5-FU 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion Repeat every 2 weeks\] or FOLFOX\[Oxaliplatin 85 mg/m2 IV over 2 hours, day 1;Leucovorin 400 mg/m2 IV over 2 hours, day 1 5-FU 400 mg/m2 IV bolus on day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks\] or CapeOX\[Oxaliplatin 130 mg/m2 IV over 2 hours, day 1 Capecitabine 850-1000mg/m2 twice daily PO for 14 days Repeat every 3 weeks\] was adopted in this control arm.

Drug: FOLFIRI/FOLFOX/CapeOX

Interventions

Cetuximab plus FOLFIRI/FOLFOXDRUG

cetuximab was added into the routine perioperative chemotherapy(FOLFIRI/FOLFOX) to evaluate its safety and efficacy

Also known as: Erbitux, C225
chemotherapy plus cetuximab
FOLFIRI/FOLFOX/CapeOXDRUG

to evaluate its safety and efficacy of routine perioperative chemotherapy(FOLFIRI/FOLFOX/CapeOX)

Also known as: XELOX
perioperative chemotherapy alone

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • good performance status
  • pathologic diagnosis of colorectal cancer
  • Rat sarcoma viral oncogene homolog(RAS) wild-type
  • radiologic confirmation the resectability of liver metastases
  • enough future liver remnant
  • Clinical Risk Score≥3
  • treatment naive
  • extra-hepatic metastases could be resected completely, if exist

You may not qualify if:

  • poor performance status, could not tolerate chemotherapy or operation
  • other malignancy history or synchronously
  • extra-hepatic metastases could not be resected completely, if exist
  • received other treatment previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (2)

  • Primrose J, Falk S, Finch-Jones M, Valle J, O'Reilly D, Siriwardena A, Hornbuckle J, Peterson M, Rees M, Iveson T, Hickish T, Butler R, Stanton L, Dixon E, Little L, Bowers M, Pugh S, Garden OJ, Cunningham D, Maughan T, Bridgewater J. Systemic chemotherapy with or without cetuximab in patients with resectable colorectal liver metastasis: the New EPOC randomised controlled trial. Lancet Oncol. 2014 May;15(6):601-11. doi: 10.1016/S1470-2045(14)70105-6. Epub 2014 Apr 7.

    PMID: 24717919BACKGROUND

  • Fong Y, Fortner J, Sun RL, Brennan MF, Blumgart LH. Clinical score for predicting recurrence after hepatic resection for metastatic colorectal cancer: analysis of 1001 consecutive cases. Ann Surg. 1999 Sep;230(3):309-18; discussion 318-21. doi: 10.1097/00000658-199909000-00004.

    PMID: 10493478RESULT

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm Metastasis

Interventions

CetuximabFolfox protocolXELOX

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Baocai Xing, MD

    Beijing Cancer Hospital,Peking University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate director

Study Record Dates

First Submitted

December 4, 2016

First Posted

January 25, 2017

Study Start

January 1, 2016

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

February 1, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)