NCT03401294

Brief Summary

Most patients with mCRC are treated with palliative chemotherapy and only a small number of patients with limited metastatic disease achieve long-term remission following metastasectomy. There is a growing need for more effective treatment in patients with liver-only mCRC to improve the rate of curative resection without compromising QOL.The current study is informed by our patient's needs. It aims to evaluate the rate of conversion therapy in patients with unresectable liver-only mCRC using the combination of FOLFOXIRI and bevacizumab and to assess the association between an early FDG-PT/CT response and other clinical and pathological biomarkers and hepatic metastasectomy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
8mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress61%
May 2025Dec 2026

First Submitted

Initial submission to the registry

January 2, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
7.3 years until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

1.7 years

First QC Date

January 2, 2018

Last Update Submit

May 7, 2025

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic colorectal cancerConversion therapyLiver Metastasectomy

Outcome Measures

Primary Outcomes (1)

  • Rate of liver metastasectomy

    Conversion From Unresectable To Resectable Liver Metastases

    Up to 3 years from the date of enrolment into the study

Secondary Outcomes (8)

  • Response rate

    Up to 12 weeks of last cycle of FOLFOXIRI from the date of enrolment till the date of maximum response

  • 30 days rates of Grade III and IV toxicity

    Up to 30 days of last cycle of FOLFOXIRI from the date of enrolment till the date of toxicity

  • The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)

    up to 3 years from the date of enrolment or till the progression of the disease

  • The European Organization for Research and Treatment of Cancer (EORTC) Colorectal Cancer Module (QLQ-CR29)

    up to 3 years from the date of enrolment or till the progression of the disease

  • The European Organization for Research and Treatment of Cancer (EORTC) Colorectal Liver Metastases Module (LMC21)

    up to 3 years from the date of enrolment or till the progression of the disease

  • +3 more secondary outcomes

Study Arms (1)

Single arm

OTHER

FOLFOXIRI and Bevacizumab

Drug: FOLFOXIRI and Bevacizumab

Interventions

FOLFOXIRI and BevacizumabDRUG

Every 2 week for a total of 12 cycles

Also known as: 5FU, leucovorin, oxaliplatin, irinotecan and bevacizumab
Single arm

Eligibility Criteria

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

You may qualify if:

  • Adult patients, aged between 18 and 70 years with histologically proven adenocarcinoma or poorly differentiated carcinoma of the colon and rectum with unresectable liver-only metastases and no extra-hepatic disease.
  • World Health Organization (WHO) performance status of 0-1.
  • No previous chemotherapy for advanced disease.
  • Adequate functioning of the bone marrow, liver, and kidneys.

You may not qualify if:

  • Breastfeeding or pregnancy.
  • An active second primary cancer with the exception of squamous cell carcinoma of the skin or an in situ cancer.
  • Severe or uncompensated concomitant medical conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allan Balir Cancer Center

Regina, Saskatchewan, Canada

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

BevacizumabFluorouracilLeucovorinOxaliplatinIrinotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCoordination ComplexesOrganic ChemicalsCamptothecinAlkaloids

Study Officials

  • Shahid Ahmed, MD, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahid Ahmed, MD, PhD

CONTACT

3066552710shahid.ahmed@saskcancer.ca

Michael Moser

CONTACT

(306) 966-8641michael.moser@usask.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 2, 2018

First Posted

January 17, 2018

Study Start

May 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 9, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)