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

Neoplasm Metastasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178243
• Other study ID #: URCC 2298
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: September 6, 2006

Study information

• Verified date: September 2006
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Procedure:
• 3D Conformal Radiation Therapy and Radiosurgery

Locations

Country	Name	City	State
United States	University of Rochester, Dept. Radiation Oncology	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States,