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

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: NCT00178243
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 8, 2006
Information provided by:
University of Rochester

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.

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

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Information from the National Library of Medicine

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

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

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): NCT00178243

United States, New York
University of Rochester, Dept. Radiation Oncology
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Principal Investigator: Paul Okunieff, MD Universtiy of Rochester, Dept of Radiation Oncology Identifier: NCT00178243     History of Changes
Other Study ID Numbers: URCC 2298
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 8, 2006
Last Verified: September 2006

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