Treatment to make inoperable liver cancer operable
Conversion From Unresectable To Resectable Liver Metastases In Patients With Liver-Only Metastatic Colorectal Cancer Treated With FOLFOXIRI Plus Bevacizumab. The Conversion Trial.
This study is testing a combination treatment to see if it can make liver cancer that can't currently be operated on eligible for surgery in patients with metastatic colorectal cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Saskatchewan Academic / other |
| Drugs / interventions | chemotherapy, bevacizumab |
| Locations | 1 site (Regina, Saskatchewan) |
| Trial ID | NCT03401294 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a combination therapy using FOLFOXIRI and bevacizumab in patients with unresectable liver-only metastatic colorectal cancer. The goal is to convert these patients to a state where surgical resection of liver metastases is possible. The study will assess the conversion rate, disease control, survival, quality of life, and the relationship between early imaging responses and surgical outcomes. A total of 32 eligible patients will be treated and monitored at major cancer centers in Saskatchewan.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with unresectable liver-only metastatic colorectal cancer and no prior chemotherapy for advanced disease.
Not a fit: Patients with extra-hepatic disease or those with severe medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly increase the number of patients with liver-only metastatic colorectal cancer who can undergo potentially curative surgery.
How similar studies have performed: Other studies have shown promising results with similar combination therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Regina, Saskatchewan
- Allan Balir Cancer Center — Regina, Saskatchewan, Canada (Recruiting)
Study contacts
- Principal investigator: Shahid Ahmed, MD, PhD — University of Saskatchewan
- Study coordinator: Shahid Ahmed, MD, PhD
- Email: shahid.ahmed@saskcancer.ca
- Phone: 3066552710
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.