Conversion From Unresectable To Resectable Metastatic Colorectal Cancer.

Metastatic Colorectal Cancer Clinical Trial

— CONVERSION  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03401294
• Other study ID #: 99268
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2024
• Source: University of Saskatchewan
• Contact: Shahid Ahmed, MD, PhD
• Phone: 3066552710
• Email: shahid.ahmed[@]saskcancer.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• FOLFOXIRI and Bevacizumab
Every 2 week for a total of 12 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of liver metastasectomy	Conversion From Unresectable To Resectable Liver Metastases	Up to 3 years from the date of enrolment into the study
Secondary	Response rate	Based on RECIST criteria	Up to 12 weeks of last cycle of FOLFOXIRI from the date of enrolment till the date of maximum response
Secondary	30 days rates of Grade III and IV toxicity	As per National Cancer Institute Common Toxicity Criteria	Up to 30 days of last cycle of FOLFOXIRI from the date of enrolment till the date of toxicity
Secondary	The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)	Quality of life questionnaire related to cancer and its treatment	up to 3 years from the date of enrolment or till the progression of the disease
Secondary	The European Organization for Research and Treatment of Cancer (EORTC) Colorectal Cancer Module (QLQ-CR29)	Quality of life questionnaire specifically related to colorectal cancer	up to 3 years from the date of enrolment or till the progression of the disease
Secondary	The European Organization for Research and Treatment of Cancer (EORTC) Colorectal Liver Metastases Module (LMC21)	Quality of life questionnaire specifically related to liver metastases	up to 3 years from the date of enrolment or till the progression of the disease
Secondary	Early-PET scan response	change in FDG-uptake between baseline and after 4 cycles of chemotherapy and it correlation with rate of metastasectomy	From the date of enrolment till 8 weeks after four cycles of FOLOXIRI and bevacizumab
Secondary	Progression-free survival	progression following FOLOXIRI and bevacizumab	up to 5 years from the time of enrolment till disease progression or last follow up visit
Secondary	Overall survival	all cause mortality	up to 5 years from the time of enrolment till mortality or last follow up visit