Conversion From Unresectable To Resectable Metastatic Colorectal Cancer.

• Status: Not yet recruiting
• Trial end date: 2026-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Saskatchewan
• Treatments: Bevacizumab; Irinotecan; Leucovorin; Oxaliplatin

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.