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Feasibility Study of Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma


N/A
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Hepatocellular, Intrahepatic Cholangiocarcinoma

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Trial Information

Feasibility Study of Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma


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 4 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 8 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Stereotactic radiation therapy (either photon or proton) can be delivered to the liver with a less than 10% 3-month incidence of Grade 4 study related toxicity.

Outcome Time Frame:

Up to 90 days after end of radiation therapy

Safety Issue:

Yes

Principal Investigator

Parag Parikh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

09-1345 / 201107319

NCT ID:

NCT01668134

Start Date:

September 2009

Completion Date:

December 2018

Related Keywords:

  • Carcinoma, Hepatocellular
  • Intrahepatic Cholangiocarcinoma
  • Carcinoma
  • Cholangiocarcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Washington University School of Medicine Saint Louis, Missouri  63110