NCT03401294 Conversion From Unresectable To Resectable Metastatic Colorectal Cancer.
| NCT ID | NCT03401294 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Saskatchewan |
| Condition | Metastatic Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 32 participants in total. It began in 2025-05-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Shahid Ahmed, MD, PhD
PRINCIPAL INVESTIGATOR
University of Saskatchewan
Frequently Asked Questions
Who can join the NCT03401294 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Metastatic Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03401294 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03401294 currently recruiting?
Yes, NCT03401294 is actively recruiting participants. Contact the research team at shahid.ahmed@saskcancer.ca for enrollment information.
Where is the NCT03401294 trial being conducted?
This trial is being conducted at Regina, Canada.
Who is sponsoring the NCT03401294 clinical trial?
NCT03401294 is sponsored by University of Saskatchewan. The principal investigator is Shahid Ahmed, MD, PhD at University of Saskatchewan. The trial plans to enroll 32 participants.
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