Conversion From Unresectable To Resectable Metastatic Colorectal Cancer.

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.

• Response rate [Срок оценки: Up to 12 weeks of last cycle of FOLFOXIRI from the date of enrolment till the date of maximum response]
• 30 days rates of Grade III and IV toxicity [Срок оценки: Up to 30 days of last cycle of FOLFOXIRI from the date of enrolment till the date of toxicity]
• The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) [Срок оценки: up to 3 years from the date of enrolment or till the progression of the disease]
• The European Organization for Research and Treatment of Cancer (EORTC) Colorectal Cancer Module (QLQ-CR29) [Срок оценки: up to 3 years from the date of enrolment or till the progression of the disease]
• The European Organization for Research and Treatment of Cancer (EORTC) Colorectal Liver Metastases Module (LMC21) [Срок оценки: up to 3 years from the date of enrolment or till the progression of the disease]
• Early-PET scan response [Срок оценки: From the date of enrolment till 8 weeks after four cycles of FOLOXIRI and bevacizumab]
• Progression-free survival [Срок оценки: up to 5 years from the time of enrolment till disease progression or last follow up visit]
• Overall survival [Срок оценки: up to 5 years from the time of enrolment till mortality or last follow up visit]