Conversion From Unresectable To Resectable Metastatic Colorectal Cancer. (CONVERSION)

November 27, 2023 updated by: Shahid Ahmed, University of Saskatchewan

Conversion From Unresectable To Resectable Liver Metastases In Patients With Liver-Only Metastatic Colorectal Cancer Treated With FOLFOXIRI Plus Bevacizumab. The Conversion Trial.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Colorectal cancer is the second leading cause of cancer-related death in North America. Patients with metastatic colorectal cancer generally have limited life expectancy, however, a small number of patients with liver-only metastases could potentially be cured following surgical resection of metastases. Patients and their family strongly feel that there is an unmet need for a more effective treatment in metastatic colorectal cancer to improve disease response rate and thereby curative surgery. Recent evidence suggest that a triplet chemotherapy regimen, FOLFOXIRI plus bevacizumab has been associated with higher response rates. The CONVERSION trial will evaluate the rate of conversion from unresectable to resectable liver metastases in patients with liver-only metastatic colorectal cancer treated with FOLFOXIRI-bevacizumab. Furthermore, this study will assess disease control rate, survival, quality of life and association between various biomarkers including an early FDG-PET/CT response and curative surgery. Thirty-two eligible patients will be recruited at the two major cancer centers in Saskatchewan. Patients will receive FOLFOXIRI-bevacizumab every two weeks for a total of 12 cycles and will undergo periodic imaging studies. The resectability of liver metastases will be assessed by a multidisciplinary team comprised of surgeons, radiologists, and oncologists. This study will be helpful to establish a standard chemotherapy regimen for patients with liver-only metastatic colorectal cancer and to determine the role of FDG-PET/CT scan and other biomarkers in predicting curative surgery. Complete resection of metastases will allow such patients to discontinue chemotherapy and live a normal life.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single arm
FOLFOXIRI and Bevacizumab
Drug: FOLFOXIRI and Bevacizumab
Every 2 week for a total of 12 cycles
Other Names:
  • 5FU, leucovorin, oxaliplatin, irinotecan and bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of liver metastasectomy
Time Frame: Up to 3 years from the date of enrolment into the study
Conversion From Unresectable To Resectable Liver Metastases
Up to 3 years from the date of enrolment into the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: Up to 12 weeks of last cycle of FOLFOXIRI from the date of enrolment till the date of maximum response
Based on RECIST criteria
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
Time Frame: Up to 30 days of last cycle of FOLFOXIRI from the date of enrolment till the date of toxicity
As per National Cancer Institute Common Toxicity Criteria
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)
Time Frame: up to 3 years from the date of enrolment or till the progression of the disease
Quality of life questionnaire related to cancer and its treatment
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)
Time Frame: up to 3 years from the date of enrolment or till the progression of the disease
Quality of life questionnaire specifically related to colorectal cancer
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)
Time Frame: up to 3 years from the date of enrolment or till the progression of the disease
Quality of life questionnaire specifically related to liver metastases
up to 3 years from the date of enrolment or till the progression of the disease
Early-PET scan response
Time Frame: From the date of enrolment till 8 weeks after four cycles of FOLOXIRI and bevacizumab
change in FDG-uptake between baseline and after 4 cycles of chemotherapy and it correlation with rate of metastasectomy
From the date of enrolment till 8 weeks after four cycles of FOLOXIRI and bevacizumab
Progression-free survival
Time Frame: up to 5 years from the time of enrolment till disease progression or last follow up visit
progression following FOLOXIRI and bevacizumab
up to 5 years from the time of enrolment till disease progression or last follow up visit
Overall survival
Time Frame: up to 5 years from the time of enrolment till mortality or last follow up visit
all cause mortality
up to 5 years from the time of enrolment till mortality or last follow up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Investigators

  • Principal Investigator: Shahid Ahmed, MD, PhD, University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 16, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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