Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

The Washington University

Status and phase

Completed

Phase 1

Conditions

Carcinoma, Hepatocellular

Intrahepatic Cholangiocarcinoma

Treatments

Radiation: Stereotactic radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT01668134

09-1345 / 201107319

Details and patient eligibility

About

This study is being done to determine if targeted radiation therapy (stereotactic) can be given to treat liver cancer, for patient who are unable to undergo surgery, over a short period of time with a small amount of side effects.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18
Karnofsky Performance Status of ≥ 60
Pathologically confirmed IHC or HCC. (Pathology not required for HCC if the lesion enhances typically on MRI and the patient is evaluated by liver transplant surgery team and thought to have HCC.)
4 or less separate intrahepatic lesions, with at least one lesion that is able to be followed by EASL Criteria.
Local surgical resection is not possible due to tumor or patient factors
Limited metastatic disease is allowed if the volume of metastatic disease does not exceed the volume of primary disease.
Prior TACE allowed if stopped/completed at least 2 weeks prior to enrollment
Prior chemotherapy except Sorafenib allowed if stopped/completed at least 2 weeks prior to enrollment
Prior Sorafenib allowed if stopped/completed at least seven days prior to enrollment.
Able to provide signed informed consent

Exclusion criteria

Childs-Pugh score 9 or more
ALT or AST ≥ 6 x upper limit of normal
Prior history of abdominal irradiation
Women who are pregnant or nursing
Scheduled to undergo chemotherapy except Sorafenib at the time when radiation therapy will be given, or for up to 4 weeks after completion of radiation therapy.
Scheduled to undergo Sorafenib within seven days of when radiation therapy will be delivered, or for up to 2 weeks after completion of radiation therapy.
Undergone prior radiation therapy to the abdomen.