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

September 6, 2006 updated by: University of Rochester

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester, Dept. Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Paul Okunieff, MD, Universtiy of Rochester, Dept of Radiation Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

September 8, 2006

Last Update Submitted That Met QC Criteria

September 6, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URCC 2298

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoplasm Metastasis

Clinical Trials on 3D Conformal Radiation Therapy and Radiosurgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe