Clinical trial NCT00178243: Feasibility of Treatment of Cancer Involving the Liver With High Dose Radiation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Neoplasms
Neoplasm Metastasis
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester, Dept. Radiation Oncology
state: New York
Study officials:
affiliation: Universtiy of Rochester, Dept of Radiation Oncology
name: Paul Okunieff, MD
role: PRINCIPAL_INVESTIGATOR
References: