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A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma (RAD 0902)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01247298
First Posted: November 24, 2010
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Rojymon Jacob, University of Alabama at Birmingham
  Purpose
This investigational study will evaluate if using a combination of TACE along with high dose SBRT would show improvement in local control in patients with Hepatocellular Carcinoma.

Condition Intervention Phase
Hepatocellular Carcinoma (HCC) Combination Product: Stereotactic Body Radiation Therapy (SBRT) Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RAD 0902: A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma

Further study details as provided by Dr. Rojymon Jacob, University of Alabama at Birmingham:

Primary Outcome Measures:
  • Safety of a Combination Therapy [ Time Frame: Baseline to 45 day after completing combination treatment. ]
    Evaluate the safety of a combination of TACE and high dose SBRT. Patients were evaluated for toxicity during their follow-up exams every 3 months for 2 years while participating in this study. Patients were also instructed to notify the PI between visits if any related toxicity issues occurred.

  • Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT. [ Time Frame: Baseline to up to 2 years after treatment completed ]
    Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months until complete response or progression. This will be measured by tumor progression and/or death on follow-up imaging from completion of treatment.

  • Local Recurrence Rate [ Time Frame: Baseline to up to 2 years after treatment completed ]
    Evaluate the number of patients with local recurrence. Patient will be asked to visit their study doctor for follow-up exams every 3 months for 2 years while participating in this study.Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months. This will be measured by number of patients with recurrence on their follow-up imaging.


Secondary Outcome Measures:
  • Percentage of Participants With Overall Survival [ Time Frame: up to 2 years after treatment completed ]
    Assess overall survival (OS) of patients treated with TACE & SBRT. This is assessed by the length of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease are still alive.

  • Percentage of Participants With Local Failure Patterns [ Time Frame: Baseline up to 2 years after treatment completed ]
    Assess local failure patterns of patients treated with TACE & SBRT. This is assessed by the percentage of patients where recurrence occurred


Enrollment: 17
Study Start Date: October 2010
Study Completion Date: December 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Body Radiation Therapy (SBRT)
Patients will receive stereotactic body radiation therapy (SBRT) which is 3 radiation treatments at 15 Gy, for a total of 45 Gy. Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. (TACE is not performed as part of this clinical study, even though it is part of the inclusion criteria.)
Combination Product: Stereotactic Body Radiation Therapy (SBRT)
This investigational study will evaluate the combination of TACE along with high dose SBRT. TACE has been used extensively in the palliative treatment of hepatocellular carcinoma (HCC). It will be performed by the Interventional Radiologist prior to radiation therapy.
Other Name: TACE

Detailed Description:

Primary objectives of this research

  1. Evaluate the safety of a combination of TACE and high dose SBRT
  2. Measure time to progression (TTP) and local recurrence rate of HCC treated with a combination of TACE & SBRT.

Secondary objectives of this research

  1. Assess failure patterns and survival of patients treated with TACE & SBRT.
  2. Analyze dose volume characteristics that influence Radiation Induced Liver Disease (RILD) among patients treated with a combination of TACE and SBRT.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Diagnosis

Patients meeting all the following criteria will be considered for enrollment:

  • Pathologically confirmed HCC -OR
  • HCC greater than 2 cm with classic radiographic findings on 2 separate testing modalities, or an HCC greater than 2 cm with a serum alpha feto-protein greater than 200.

Lesions:

Single liver lesion: measuring 3 cm to ≤ 8 cm*.

  • Multiple liver lesions: ≤ 3 liver lesions, none measuring over 5 cm, provided all lesions are considered for TACE.
  • Lesions <3 cm if they are in an unfavorable location for ablation† *The size criteria of hepatic lesions are also subjected to the dose volume constraints for radiotherapy, as described below.

Patient

  • Patient deemed to not candidate or should have refused liver-transplant, surgery or RFA.
  • Patient must be a candidate and receive TACE.
  • ECOG (Eastern Cooperative Oncology Group) Zubrod Performance Scale = 0-1.
  • Age > 19
  • Patient should not be pregnant. Women of childbearing potential and male participants must practice adequate contraception.

Adequate hematological profile and adequate liver functions. Signed informed consent document

Imaging studies completed at least 60 days prior to study entry. Evaluated by radiation oncologist within 2 weeks prior to study entry.

Exclusion Criteria:

Patients presenting with any of the following will not be included in the study:

  1. Prior invasive malignancies
  2. Prior radiotherapy to the liver or surrounding areas.
  3. Systemic therapy using any chemotherapy and/or targeted agents given within 2 weeks prior to TACE, during RT, and / or within 3 weeks following RT
  4. Severe medical co-morbidities
  5. INR (international normalized ratio) > 2 times upper level normal
  6. Uncontrolled or symptomatic clinical ascites
  7. Major surgical procedure within 3 weeks prior to study entry.
  8. History of hypersensitivity to chemotherapy agents, contrast material.
  9. Pregnancy, breast-feeding or planning to become pregnant.
  10. Treatment with any investigational product in the last 4 weeks before study entry.
  11. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

Patients of Reproductive Potential The patient must not be pregnant or breast-feeding at enrollment in the study. Absence of pregnancy must be demonstrated by serum or urine testing prior to enrollment into the study.

Female patients of child bearing potential (i.e., ovulating, premenopausal, not surgical sterile) must use a medically accepted contraceptive regimen. Male patients must agree to use a medically approved method of contraception.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247298


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Rojymon Jacob, MD, FRCR University of Alabama at Birmingham/Department of Radiation Oncology
Principal Investigator: Derek A. Dubay, MD University of Alabama at Birmingham Department of Hepatobiliary Surgery
  More Information

Responsible Party: Dr. Rojymon Jacob, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01247298     History of Changes
Other Study ID Numbers: F100708009
First Submitted: November 22, 2010
First Posted: November 24, 2010
Results First Submitted: December 28, 2016
Results First Posted: June 19, 2017
Last Update Posted: August 21, 2017
Last Verified: July 2017

Keywords provided by Dr. Rojymon Jacob, University of Alabama at Birmingham:
Hepatocellular Carcinoma (HCC)
Trans-Arterial Chemobolizaion (TACE)
Radiation Induced Liver Disease (RILD)
Stereotactic Body Radiation Therapy (SBRT)

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases