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OpenTrials
Completed

NCT Number: NCT01668134

Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stereotactic Radiation

Radiation

Primary outcomes

  1. 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.

    Time frame: Up to 90 days after end of radiation therapy

Secondary outcomes

  1. Measure the late toxicity associated with using stereotactic radiation therapy in patients with unresectable HCC and IHC.

    Time frame: Up to 60 days after end of radiation therapy

  2. Measure the local recurrence rates associated with using SBRT in patients with unresectable HCC and IHC.

    Time frame: Time of treatment until recurrance or progressive disease as measured by CT/MR from baseline to recurrance or progressive disease

  3. Measure the overall survival rates associated with using SBRT in patients with unresectable HCC and IHC.

    Time frame: Baseline to time of death

  4. Measure the response rates associated with using SBRT in patients with resectable HCC and IHC

    Time frame: Baseline to the first date of recurrance or progressive disease

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Aug 17, 2012
Registry last updated
Feb 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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