Clinical trial

Conversion From Unresectable To Resectable Liver Metastases In Patients With Liver-Only Metastatic Colorectal Cancer Treated With FOLFOXIRI Plus Bevacizumab. The Conversion Trial.

Name
99268
Description
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.
Trial arms
Trial start
2024-09-01
Estimated PCD
2026-03-31
Trial end
2026-03-31
Status
Not yet recruiting
Phase
Early phase I
Treatment
FOLFOXIRI and Bevacizumab
Every 2 week for a total of 12 cycles
Arms:
Single arm
Other names:
5FU, leucovorin, oxaliplatin, irinotecan and bevacizumab
Size
32
Primary endpoint
Rate of liver metastasectomy
Up to 3 years from the date of enrolment into the study
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ESTIMATED'}}
Updated at
2024-05-08

1 organization

1 product

1 indication