ClinicalTrials.gg
RecruitingNCT03401294CONVERSIONUpdated May 9, 2025

Conversion From Unresectable To Resectable Metastatic Colorectal Cancer.

A Phase 2 interventional study of FOLFOXIRI and Bevacizumab in Metastatic Colorectal Cancer, sponsored by University of Saskatchewan. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-09.

Sponsored by University of Saskatchewan · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.

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Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 230 studies testing bevacizumab in Colorectal Neoplasms — 49 open to participants now, 61 under way, 11 of them phase 3. Bevacizumab · Colorectal Neoplasms.

Planned enrollment
167th of 224
32 · median 63
Started
2025
with 12 others
Phase 2
133 of 230
31 open now
Primary completion
2026-12
later than 29 of 60 live
Registered
154th of 230
by date

Among the 230 studies testing bevacizumab in Colorectal Neoplasms, this one is the 167th largest by planned enrollment of the 224 interventional ones that give a count, is one of 13 that started in 2025, is one of 133 in phase 2, reaches primary completion later than 29 of the 60 other live ones, and was the 154th registered.

Colorectal Neoplasms

6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.

Browse Colorectal Neoplasms studies →

Open to participants now

49 of the 230 studies testing bevacizumab in Colorectal Neoplasms are open now, in 12 countries. Recruiting first, the newest first:

43 more — sign in →

By country, each count listing its studies:

All 49 open studies →

About bevacizumab

Bevacizumab: first FDA approval 2004 (AVASTIN), first EMA approval 2005. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 1,181 Colorectal Neoplasms studies recruiting now, 764 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 230 studies testing bevacizumab in Colorectal Neoplasms, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Metastatic Colorectal Cancer

Keywords

  • Metastatic colorectal cancer
  • Conversion therapy
  • Liver Metastasectomy
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients, aged between 18 and 70 years with proven adenocarcinoma or poorly differentiated carcinoma of the colon and rectum with unresectable liver-only 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

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Other
    Single arm

    FOLFOXIRI and Bevacizumab

    Drug: FOLFOXIRI and Bevacizumab

Interventions

  • DrugFOLFOXIRI and Bevacizumab

    Drug page: Bevacizumab

    Every 2 week for a total of 12 cycles

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

06

What researchers measure

Primary outcomes

  1. Rate of liver metastasectomy

    Conversion From Unresectable To Resectable Liver Metastases

    Time frame: Up to 3 years from the date of enrolment into the study

Secondary outcomes

  1. Response rate

    Based on RECIST criteria

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

  2. 30 days rates of Grade III and IV toxicity

    As per National Cancer Institute Common Toxicity Criteria

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

  3. 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

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

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

    Quality of life questionnaire specifically related to colorectal cancer

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

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

    Quality of life questionnaire specifically related to liver metastases

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

  6. Early-PET scan response

    change in FDG-uptake between baseline and after 4 cycles of chemotherapy and it correlation with rate of metastasectomy

    Time frame: From the date of enrolment till 8 weeks after four cycles of FOLOXIRI and bevacizumab

  7. Progression-free survival

    progression following FOLOXIRI and bevacizumab

    Time frame: up to 5 years from the time of enrolment till disease progression or last follow up visit

  8. Overall survival

    all cause mortality

    Time frame: up to 5 years from the time of enrolment till mortality or last follow up visit

07

Study locations

1 of 1 sites recruiting
  • Allan Balir Cancer Center
    Regina, Saskatchewan, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for Dec 2026, 19 months after the start.

Of 498 non-industry phase 2 interventional studies under Colorectal Neoplasms, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 75. This study's planned 19 months is below that.

Counting every sponsor, half of 618 studies reached it within 49 months; a quarter within 31 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2018
First posted
Jan 17, 2018
StartActual
May 1, 2025
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
May 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03401294
Responsible party
Shahid Ahmed (Professor of Medicine, University of Saskatchewan) — Principal investigator
First posted
Jan 17, 2018
Start date
May 1, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 9, 2025

Study contacts

Shahid Ahmed, MD, PhD
Contact
shahid.ahmed@saskcancer.ca
3066552710
Michael Moser
Contact
michael.moser@usask.ca
(306) 966-8641
Shahid Ahmed, MD, PhD
principal investigator · University of Saskatchewan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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