Please select the eligibility criteria that correspond to the clinical trial below.
Title: Pre- and Post-Operative Chemotherapy With Oxaliplatin 5FU/LV Versus Surgery Alone in Resectable Liver Metastases From Colorectal Origin - Phase III Study
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with surgery may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for liver metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have liver metastases from colorectal cancer.


Options:
A: Inclusion Criteria:

* Age \> 18 years
* Child-Pugh Class A or B

Exclusion Criteria:

* Informed consent not available
* Presence of portal vein thrombosis, portal vein tumor thrombus, or previous portal vein embolisation
* Presence of hepatic artery thrombosis, previous transarterial therapy like TACE, or transarterial internal radiation
* When portal vein resection is anticipated
* Emergency hepatectomy
* Ruptured hepatocellular carcinoma
* Rehepatectomy (repeated liver resection)
* Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver
* When concomitant bowel or bile duct resection is anticipated
B: Inclusion Criteria:

* Adults (\>18 years).
* Pre-operative hemoglobin concentration \>= 11 mg/dl (males); \>= 10 mg/dl (females) within 14 days of registration.
* Patients scheduled for resection of 3 or more liver segments for any indication, with or without other planned procedures or patients scheduled for pancreaticoduodenectomy

Exclusion Criteria:

* A history of active coronary artery disease. Patients with a history of coronary artery disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal left ventricular (LV) function within 30 days of operation.
* A history of cerebrovascular disease.
* A history of congestive heart failure.
* A history of uncontrolled hypertension.
* A history of restrictive or obstructive pulmonary disease.
* A history of renal dysfunction (creatinine \[Cr\] \> 1.8).
* Abnormal coagulation parameters (International Normalized Ratio \[INR\] \> 1.5 not on Coumadin, or platelet count \< 100,000).
* Presence of active infection.
* Evidence of hepatic metabolic disorder (bilirubin \> 2 mg/dl, ALT \> 75 U/L in the absence of biliary tract obstruction).
* Pre-operative autologous blood donation.
C: DISEASE CHARACTERISTICS:

* Diagnosis of potentially resectable colorectal liver metastases that meets one of the following criteria:

  * Metachronous metastases after complete resection of primary tumor without gross or microscopic evidence of residual disease
  * Synchronous metastases after complete resection of primary tumor more than 1 month before study
  * Synchronous metastases with sufficient evidence (i.e., CAT scan or diagnostic laparoscopy) that both the primary tumor and liver metastases can be completely resected during the same procedure and resection of primary may be delayed 3-4 months

PATIENT CHARACTERISTICS:

Age:

* 18 to 80

Performance status:

* WHO 0-2
* Karnofsky 60-100%

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* No hepatic insufficiency

Renal:

* Creatinine less than 2 times upper limit of normal

Cardiovascular:

* No uncontrolled congestive heart failure or angina pectoris
* No hypertension or arrhythmia

Other:

* No other malignancy within the past 10 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer
* No peripheral neuropathy greater than grade 1
* No prior significant neurologic or psychiatric disorders
* No active infection
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent biologic therapy

Chemotherapy:

* No prior chemotherapy for advanced disease
* Prior adjuvant chemotherapy for primary cancer allowed unless included oxaliplatin
* No other concurrent chemotherapy

Endocrine therapy:

* No concurrent anticancer endocrine therapy

Radiotherapy:

* No concurrent radiotherapy

Surgery:

* See Disease Characteristics

Other:

* At least 30 days since prior investigational drugs
* No concurrent investigational drugs
D: Inclusion Criteria:

* patients \> 18 years of age and \< 100 years of age
* primary or secondary liver tumours requiring liver surgery

Exclusion Criteria:

* pre-existent liver disease (e.g. inflammatory liver disease, cirrhosis, inborn errors of metabolism)
* cholangiocarcinoma requiring biliary tract reconstruction during surgery
* steroid hormone medication
* tumours deemed irresectable during liver surgery
* laparoscopic liver surgery

Answer: C