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

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178243
First received: September 12, 2005
Last updated: September 6, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Liver Neoplasms
Neoplasm Metastasis
Procedure: 3D Conformal Radiation Therapy and Radiosurgery
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Rochester:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178243

Locations
United States, New York
University of Rochester, Dept. Radiation Oncology
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Paul Okunieff, MD Universtiy of Rochester, Dept of Radiation Oncology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00178243     History of Changes
Other Study ID Numbers: URCC 2298
Study First Received: September 12, 2005
Last Updated: September 6, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Liver Neoplasms
Neoplasm Metastasis
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014