Cryosurgery in Treating Patients With Unresectable Liver Metastases From Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002997
• Other study ID #: CDR0000065545
• Secondary ID: ECOG-1296
• Status: Completed
• Phase: Phase 2
• Start date: February 4, 1998
• Est. completion date: March 2, 2004

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2, 2004
• Est. primary completion date: January 31, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Procedure:
• cryosurgery

Locations

Country	Name	City	State
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania
United States	University of Rochester Cancer Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,