Colorectal Adenocarcinoma, Liver Metastases
Conditions
Keywords
resectable liver metastases, colorectal adenocarcinoma, survival, neoadjuvant chemotherapy
Brief summary
When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. This study will determine if giving chemotherapy treatment before the surgery can reduce the chances that the cancer will come back.
Detailed description
When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. This study will determine if giving chemotherapy treatment before the surgery can reduce the chances that the cancer will come back.
Interventions
Sponsors
Pfizer
Alberta Health services
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* stage IV colorectal cancer isolated to the liver * one measurable lesion * metastases are completely resectable or amenable to ablation * Karnofsky \>70 * Adequate bone marrow function * adequate hepatic function * adequate renal function * informed consent
Exclusion criteria
* primary tumor not controlled by locoregional treatments * bilateral portal vein and/or hepatic artery involvement * previous chemotherapy directed at treatment of metastatic colorectal cancer * underlying acute or chronic liver disease * Gilbert's disease * patients receiving phenytoin or phenobarbital prophylaxis * presence of any concurrent medical or psychiatric condition that serves as a contraindication to surgery or chemotherapy * pregnancy * malignancy other than basal cell or squamous cell carcinoma of the skin within the preceding 5 years * use of another investigational medication concurrently or within 4 months of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival | — |
Countries
Canada
Outcome results
None listed