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Feasibility of Treatment of Cancer Involving the Liver With High Dose Radiation

Primary Purpose

Liver Neoplasms, Neoplasm Metastasis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
3D Conformal Radiation Therapy and Radiosurgery
Sponsored by
University of Rochester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have new hepatic lesions suggestive of metastasis, or otherwise biopsy proven disease if there is no previously negative scan. Patients with chemotherapy responsive or resistant disease are acceptable. Primary hepatobiliary tumors are also acceptable. In each case, the patient must be deemed unresectable by a hepatic surgeon. Patients with multiple hepatic lesions may be included if they meet the volumetric criteria for dose specification. Likewise, patients with metastases to organs other than the liver, or patients with residual primary disease may be included if it is judged that longevity will be determined by the hepatic disease. KPS ≥70 Age ≥ 18 years Bilirubin <2.0 mg/dl, AST < 2.5 x normal, ALT < 2.5 x normal, Platelets > 80,000/mm3 Chemotherapy treatment before or after radiation will be allowed Informed consent must be obtained., Patient must be judged unresectable by a hepatic surgeon, or must have refused surgery Patient must be able to tolerate radiation treatment as judged by the Principal Investigator or co-PI. Previous Liver resection is allowed Active disease outside the liver is allowed. Liver lesion should be visible on CT or MRI. Exclusion Criteria: No active hepatitis or radiographic evidence of diffuse macro-nodular cirrhosis. Patients with lesser degrees of cirrhosis, not associated with portal hypertension or hepatic failure, are eligible but radiation schedule and total dose will be appropriately modified. Women who are pregnant

Sites / Locations

  • University of Rochester, Dept. Radiation Oncology

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
September 6, 2006
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT00178243
Brief Title
Feasibility of Treatment of Cancer Involving the Liver With High Dose Radiation
Official Title
A Phase I/II Trial Of the Feasibility of Treatment of Cancer Involving the Liver With High Dose Radiation Delivered by 3D Conformal Radiation Therapy and Radiosurgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rochester

4. Oversight

5. Study Description

Brief Summary
A study is being conducted by the University of Rochester Cancer Center (URCC) in which patients with liver cancer will be treated with high dose conformal radiation therapy. This type of radiation uses new techniques which aim the radiation to the sites of disease allowing the tumor to receive a high dose and the surrounding normal liver tissue to receive a low enough dose that the normal tissue should remain free from injury. The purpose of the study is to determine if the conformal radiation therapy is safe, tolerable and effective in treating liver cancer and to determine the side effects caused by this treatment. A second objective is to determine if the levels of a special type of protein (called cytokines) found in the blood are related to this treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasms, Neoplasm Metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
3D Conformal Radiation Therapy and Radiosurgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have new hepatic lesions suggestive of metastasis, or otherwise biopsy proven disease if there is no previously negative scan. Patients with chemotherapy responsive or resistant disease are acceptable. Primary hepatobiliary tumors are also acceptable. In each case, the patient must be deemed unresectable by a hepatic surgeon. Patients with multiple hepatic lesions may be included if they meet the volumetric criteria for dose specification. Likewise, patients with metastases to organs other than the liver, or patients with residual primary disease may be included if it is judged that longevity will be determined by the hepatic disease. KPS ≥70 Age ≥ 18 years Bilirubin <2.0 mg/dl, AST < 2.5 x normal, ALT < 2.5 x normal, Platelets > 80,000/mm3 Chemotherapy treatment before or after radiation will be allowed Informed consent must be obtained., Patient must be judged unresectable by a hepatic surgeon, or must have refused surgery Patient must be able to tolerate radiation treatment as judged by the Principal Investigator or co-PI. Previous Liver resection is allowed Active disease outside the liver is allowed. Liver lesion should be visible on CT or MRI. Exclusion Criteria: No active hepatitis or radiographic evidence of diffuse macro-nodular cirrhosis. Patients with lesser degrees of cirrhosis, not associated with portal hypertension or hepatic failure, are eligible but radiation schedule and total dose will be appropriately modified. Women who are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Okunieff, MD
Organizational Affiliation
Universtiy of Rochester, Dept of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester, Dept. Radiation Oncology
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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Feasibility of Treatment of Cancer Involving the Liver With High Dose Radiation

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