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

Status:

COMPLETED

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

Lead Sponsor:

University of Rochester

Conditions:

Liver Neoplasms

Neoplasm Metastasis

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

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 us...

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00178243

Last Update

September 8 2006

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