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Cryosurgery in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Cryosurgery in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Cryosurgery in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer Clinical research trials and Cryosurgery in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Cryosurgery in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer. Cryosurgery in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Cryosurgery in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer clinical trial. Human subjects often get the best healthcare possible for their Cryosurgery in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Cryosurgery in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer  Cryosurgery in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer
Cryosurgery in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer
For Condition: recurrent rectal cancer,adenocarcinoma of the colon,stage 4 colon cancer,adenocarcinoma of the rectum,recurrent colon cancer,Stage 4 rectal cancer,liver metastases
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesPeacock, Study Chair, Eastern Cooperative Oncology Group
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
Additional Information:
Study ID Numbers: CDR0000065545; E-1296
Study Start Date: August 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002997
Other Stage 4 Rectal Cancer Studies:
1. Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer
2. Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
3. Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer
4. Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma
5. High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer
Related Studies:
Other Stage 4 rectal cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Cryosurgery in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer
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