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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Neoplasms, Neoplasm Metastasis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Paul Okunieff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universtiy of Rochester, Dept of Radiation Oncology

Authority:

United States: Institutional Review Board

Study ID:

URCC 2298

NCT ID:

NCT00178243

Start Date:

Completion Date:

Related Keywords:

  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Liver Neoplasms
  • Neoplasm Metastasis

Name

Location

University of Rochester, Dept. Radiation OncologyRochester, New York  14642