Metastatic Colorectal CancerPhase 2CONVERSIONNCT03401294
Conversion From Unresectable To Resectable Metastatic Colorectal Cancer.
A Phase 2 study testing FOLFOXIRI and Bevacizumab in people with Metastatic Colorectal Cancer, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- FOLFOXIRI and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Allan Balir Cancer Center
Regina, Saskatchewan
Haji Chalchal, MD, haji.chalchal@saskcancer.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- FOLFOXIRI and Bevacizumab
- Keywords
- Metastatic colorectal cancer, Conversion therapy, Liver Metastasectomy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXIRI and BevacizumabDrug
Also called 5FU, leucovorin, oxaliplatin, irinotecan and bevacizumab
Every 2 week for a total of 12 cycles
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | FOLFOXIRI and Bevacizumab Receives: Drug: FOLFOXIRI and Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of liver metastasectomy
Conversion From Unresectable To Resectable Liver Metastases
Measured: Up to 3 years from the date of enrolment into the study
Secondary outcomes (8)
Response rate
Based on RECIST criteria
Measured: 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
As per National Cancer Institute Common Toxicity Criteria
Measured: 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)
Quality of life questionnaire related to cancer and its treatment
Measured: 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)
Quality of life questionnaire specifically related to colorectal cancer
Measured: 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)
Quality of life questionnaire specifically related to liver metastases
Measured: up to 3 years from the date of enrolment or till the progression of the disease
Early-PET scan response
change in FDG-uptake between baseline and after 4 cycles of chemotherapy and it correlation with rate of metastasectomy
Measured: From the date of enrolment till 8 weeks after four cycles of FOLOXIRI and bevacizumab
Progression-free survival
progression following FOLOXIRI and bevacizumab
Measured: up to 5 years from the time of enrolment till disease progression or last follow up visit
Overall survival
all cause mortality
Measured: up to 5 years from the time of enrolment till mortality or last follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahid Ahmed, University of Saskatchewan
- Investigators
- Shahid Ahmed, MD, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401294
- Sponsor's protocol ID
- 99268
- Acronym
- CONVERSION
- Status last verified
- May 2025
- First submitted
- 2 Jan 2018
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion From Unresectable To Resectable Liver Metastases In Patients With Liver-Only Metastatic Colorectal Cancer Treated With FOLFOXIRI Plus Bevacizumab. The Conversion Trial.
- ClinicalTrials.gov ID
- NCT03401294
- Acronym / sponsor ID
- CONVERSION / 99268
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic colorectal cancer, Conversion therapy, Liver Metastasectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Drug: FOLFOXIRI and BevacizumabFOLFOXIRI and Bevacizumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFOXIRI and BevacizumabAlso: 5FU, leucovorin, oxaliplatin, irinotecan and bevacizumabEvery 2 week for a total of 12 cycles | Drug | Single arm |
Primary outcome
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
8 secondary outcomes
Response rate
Time frame: 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
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
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
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
Early-PET scan response
Time frame: 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
Overall survival
Time frame: up to 5 years from the time of enrolment till mortality or last follow up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shahid Ahmed, MD, PhD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOXIRI and Bevacizumab in people with Metastatic Colorectal Cancer, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shahid Ahmed, MD, PhD (3066552710, shahid.ahmed@saskcancer.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of liver metastasectomy (time frame: Up to 3 years from the date of enrolment into the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.