IXO+A in mCRC With Liver-only Metastases
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Registration Number
- NCT01293942
- Lead Sponsor
- Ottawa Hospital Research Institute
- Brief Summary
The percentage of patients with defined unresectable metastatic disease who will benefit from a first-line treatment enabling secondary complete metastasectomy is unknown but limited. Definition of optimized treatment algorithms is difficult due to very inhomogeneous patient populations.
This open label, multicentre Phase II study primarily aims to assess the resection rate achievable in a selected patient population with initially unresectable metastatic disease limited to the liver only in order to evaluate feasibility, safety and efficacy with regards to secondary resection of hepatic lesions in these patients.
The trial aims to enrol only patients meeting defined criteria of unresectability with regards to their hepatic lesions and will exclude patients with extrahepatic lesions in order to examine the most appropriate, highly active treatment regimen for this group of unresectable patients with the highest probability of a successful secondary metastasectomy with curative intent. The trial will be conducted in highly specialized centres with a track record of successful interdisciplinary treatment approaches in the field of metastatic colorectal cancer to allow the precise assessment of the peri-operative safety parameters as well as an evaluation of the surgical treatment approaches.
The IXO regimen selected for this study has shown in a phase I/II study promising efficacy and a favourable safety profile. Bevacizumab has demonstrated a significant survival benefit in combination with chemotherapy in metastatic colorectal cancer. Therefore the study will allow evaluation of its potential benefit in combination with the two most active current chemotherapy regimens in the first-line and post-operative treatment setting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Primary colorectal cancer with unresectable metastatic lesion(s)
- At least one measurable lesion, confirmed by CT scan
- Male and female patients, aged ≥ 18 years
- ECOG performance score of 0 or 1 (within 1 week of study treatment start)
- Written informed consent
- Adequate general condition, cardiopulmonary functions and performance status
- Liver metastases no initially foreseen R0 resection of all hepatic lesions, but deemed potentially resectable after response to downsizing therapy
- Extrahepatic metastatic disease
- Prior systemic or local treatment for metastatic disease, prior therapy with a biologic agent, prior adjuvant or neo-adjuvant chemotherapy, prior radiotherapy to the liver, other concurrent chemotherapy
- Inadequate bone marrow, liver, renal function, uncontrolled hypertension
- Pregnancy or lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IXO+A irinotecan, capecitabine, oxaliplatin (IXO) and bevacizumab IXO regimen with Avastin
- Primary Outcome Measures
Name Time Method conversion to resectability during downsizing therapy with IXO+A patients with initially unresectable liver-only metastases associated with colorectal cancer after 8 IXO+A cycles
- Secondary Outcome Measures
Name Time Method Recurrence-free survival (RFS) Every 2 cycles Progression-free survival (PFS) Every 2 cycles Time to response (TTR) Every 2 cycles Overall survival (OS) Every 2 cycles Pathological complete response (pCR) rate assessed post-operatory Overall response rate (ORR) Every 2 cycles Number of participants with Adverse Events as a measure of Safety and Tolerability Every 3 weeks Surgical safety (frequency of surgical complications) assessed post-operatory Pathological changes in the non-tumoural liver following therapy with IXO+A assessed post-operatory R0, R1, R2 resection rate after up to 8 cycles of downsizing therapy with IXO+A assessed post-operatory
Trial Locations
- Locations (4)
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
University Health Network
🇨🇦Toronto, Ontario, Canada
The Ottawa Hospital Cancer Center
🇨🇦Ottawa, Ontario, Canada