Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

NCT ID: NCT01668134

Last Updated: 2017-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-16
• Study Completion Date: 2015-12-22

Brief Summary

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.

Conditions

Carcinoma, Hepatocellular; Intrahepatic Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stereotactic radiation

Group Type: EXPERIMENTAL

Stereotactic radiation

Intervention Type: RADIATION

Interventions

Stereotactic radiation

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Parag Parikh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

09-1345 / 201107319

Identifier Type: -

Identifier Source: org_study_id