Recruiting
Phase 2

Observational Study

Sponsor:

University of Saskatchewan

Code:

NCT03401294

Conditions

Metastatic Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

FOLFOXIRI and Bevacizumab

Study Details

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.

Conditions

Metastatic Colorectal Cancer

Study ID

NCT03401294

Start date

May 1, 2025

Status verified date

May, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Single arm

FOLFOXIRI and Bevacizumab

Interventions

FOLFOXIRI and Bevacizumab

Every 2 week for a total of 12 cycles

Primary outcome measure

  • Rate of liver metastasectomy [ Time Frame: Up to 3 years from the date of enrolment into the study ]

Central Contacts and Locations

Central contacts

Shahid Ahmed, MD, PhD

3066552710shahid.ahmed@saskcancer.ca

Michael Moser

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

Locations

Allan Balir Cancer Center

Recruiting

Regina, Saskatchewan, Canada

Contacts

Haji Chalchal, MD

haji.chalchal@saskcancer.ca

More Information

Sponsor

University of Saskatchewan

Last update posted

May 9, 2025

Last verified

May, 2025

Keywords

  • Metastatic colorectal cancer
  • Conversion therapy
  • Liver Metastasectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2025-05-09.