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Cryosurgery in Treating Patients With Unresectable Liver Metastases From Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002997
Recruitment Status : Completed
First Posted : April 7, 2004
Last Update Posted : January 2, 2019
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group

Brief Summary:

RATIONALE: Cryosurgery for liver metastases may have fewer side effects and improve recovery.

PURPOSE: Phase II trial to study the effectiveness of cryosurgery for patients with unresectable liver metastases from colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Cancer Procedure: cryosurgery Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Trial of Cryoablation for Treatment of Unresectable Colorectal Hepatic Metastases
Actual Study Start Date : August 1997
Actual Primary Completion Date : January 31, 2001
Actual Study Completion Date : March 2, 2004

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002997

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United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
University of Rochester Cancer Center
Rochester, New York, United States, 14642
United States, Pennsylvania
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102-1192
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Study Chair: James L. Peacock, MD James P. Wilmot Cancer Center
Layout table for additonal information Identifier: NCT00002997    
Other Study ID Numbers: CDR0000065545
First Posted: April 7, 2004    Key Record Dates
Last Update Posted: January 2, 2019
Last Verified: December 2018
Keywords provided by Eastern Cooperative Oncology Group:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
liver metastases
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes