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Phase II Trial of Cryoablation for Treatment of Unresectable Colorectal Hepatic Metastases

Phase 2
18 Years
Not Enrolling
Colorectal Cancer, Metastatic Cancer

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Trial Information

Phase II Trial of Cryoablation for Treatment of Unresectable Colorectal Hepatic Metastases

OBJECTIVES: I. Evaluate the feasibility of conducting a multi-institutional clinical study
of cryosurgery for liver metastases. II. Evaluate the morbidity and mortality of cryosurgery
for liver metastases when applied in a multi-institutional setting. III. Evaluate the
efficacy of cryosurgery for liver metastases as measured by total liver control, local
lesion control, and overall survival.

OUTLINE: This is a multi-institutional study. Patients are first confirmed by exploratory
laparotomy to have no extrahepatic metastases. They then undergo biopsy of the portal lymph
node, after which, full mobilization of liver is recommended. Cholecystectomy is optional
but recommended for treatment of tumors adjacent to the gallbladder. After mapping out the
location and size of the metastatic tumor by ultrasound, cryoablation of the metastases is
carried out. Cryoablation involves the delivery of nitrogen through metallic probes placed
surgically into the center of the liver metastases. There are two freeze and thaw cycles for
each lesion with synchronous intraoperative ultrasound monitoring of the cryoablation. One
centimeter margin of cryoablation is determined by this ultrasound image. Treatment of the
liver with regional chemotherapy is not allowed until radiographic and pathologic
confirmation of disease progression in the liver. Follow-up is at 3 weeks after surgery and
then every 3 months.

PROJECTED ACCRUAL: There will be a maximum of 45 patients accrued in approximately 3 years
for this study. This is a two stage accrual design in which 17 patients are first accrued of
which 15 should be eligible. If fewer than 11 of the initial 15 eligible patients show no
evidence of disease at 3 months, the study stops and treatment is abandoned. If at least 11
patients show no evidence of disease, then 28 additional patients are accrued.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed primary colorectal adenocarcinoma with
synchronous and metachronous metastases to liver 1 to 5 liver metastases demonstrated by
rapid sequence CT scan or Feridex-enhanced MRI within 2 weeks of registration CT
portography not required No single metastasis greater than 6 cm Maximum liver involvement
must not be more than 40% by volume No extrahepatic metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic:
Platelet count greater than 80,000/mm3 Prothrombin time less than 15.0 seconds Hepatic:
Bilirubin less than 2.0 mg/dL Renal: Not specified Other: Must be disease free for at
least 5 years except for treated basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy
allowed No concurrent regional chemotherapy allowed Endocrine therapy: Not specified
Radiotherapy: Not specified Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

James L. Peacock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 1997

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • liver metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



University of Rochester Cancer Center Rochester, New York  14642
Hahnemann University Hospital Philadelphia, Pennsylvania  19102-1192
Hackensack University Medical Center Hackensack, New Jersey  07601