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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01247298
First received: November 22, 2010
Last updated: November 18, 2013
Last verified: November 2013
  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)
Procedure: Trans- Arterial Chemoembolization
Procedure: Stereotactic Body Radiation Therapy (SBRT)
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Primary Outcome [ Time Frame: length of study treatment is up to 45 day after completing TACE treatment. Patient will be asked to visit their study doctor for follow-up exams every 3 months for 2 years while participating in this study. ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Secondary Outcome [ Time Frame: up to 2 years after treatment completed ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TACE + SBRT
Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. (TACE is not performed as part of this clinical study.) After completion of TACE, then a multi-disciplinary tumor board will assess to see if they feel the patient is eligible for stereotactic body radiation therapy (SBRT). If eligible, they will be enrolled into the study. The patient will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.
Procedure: Trans- Arterial Chemoembolization
TACE has been used extensively in the palliative treatment of hepatocellular carcinoma (HCC). This treatment involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin. This procedure is performed by the Interventional Radiologist. Once access is established, chemotherapy drugs and contrast material are injected directly into the tumor. This procedure is performed under sedation and does not usually require hospital stay. Patient will be given antiemetics (medication to stop or prevent nausea/vomiting), antibiotics, and pain relievers after the procedure, which patient may be asked to continue for several hours.
Other Name: TACE
Procedure: Stereotactic Body Radiation Therapy (SBRT)
SRT(Stereotactic Radiation Therapy)is a technique of high precision radiation treatment.Liver is one of the body sites where SRT has been successfully used. During SBRT, patient will be asked to lie still on a treatment bed under the radiation machine.The physician uses sophisticated computers to direct the radiation beam to the tumor with great accuracy.The radiation physician will prescribe antiemetics before the treatment starts.Patient will not experience any pain or other side-effects during treatment, but may feel uncomfortable lying still for several minutes.A typical SBRT treatment may last 30 mins and there will be three treatments.Patient will be alone in treatment room, however they are constantly monitored throughout the procedure.They can communicate with the physician and technicians outside the room using a intercom.Patient will be able to listen to music during the procedure.
Other Names:
  • SBRT (Stereotactic Body Radiation Therapy)
  • SRT (Stereotactic Radiation Therapy)

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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 be a liver transplant candidate at the time of study entry(or refuse transplant).
  • Patient deemed to not be a candidate for surgical resection at the time of study entry (or refuse surgical resection).
  • Patient deemed to not be a candidate for ablation (or refuse ablation therapy).
  • 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 organ function as evidence by:

Hematology

  • Absolute neutrophil count (ANC) > 1,200 cells/mm3 < 2 weeks prior to entry
  • Platelets > 40,000 cells/mm3 < 2 weeks prior to entry into study
  • Hemoglobin > 8 g/dl < 2 weeks prior to entry into study

Liver Functions

  • Bilirubin should be < 2 times the normal limit, INR should be <2, and liver enzymes less than 3 times the normal limits drawn within 2 weeks prior to study entry.
  • Patients who have developed a tumor recurrence following a liver transplant, liver resection or liver ablation are eligible for this study.
  • Patients with Child Pugh Class A & B disease are eligible for the study; Class C patients are ineligible. Patients with normal liver function or compensated cirrhosis are eligible for the study. However, patients with poorly controlled ascites are ineligible for the study (see below).
  • Patients with clinically significant liver failure are ineligible.
  • Underlying liver cirrhosis is not a contraindication for entry, but should be recorded for analysis of relationship to toxicity development.

Signed informed consent document

Male or female patients of any ethnic group. Female patients must be surgically sterile, postmenopausal (no menses for at least one year), or using medically approved method of contraception. Men must agree to use a medically approved method of contraception.

Age > 19 years.

Imaging must be completed within 60 days of study entry. CT Simulation images may be used for both Liver and Chest imaging given that image includes the chest and the Radiation Oncologists reviews and comments on chest imaging.

Patient must be evaluated by a radiation oncologist within 2 weeks of study entry.

Exclusion Criteria:

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

  1. Prior invasive malignancies are ineligible, unless patients are free of disease for over 5 years. For example a patient cannot be registered for this study for treatment of HCC, if there is a history of prior colorectal cancer. (Patients with non-melanoma skin cancer or in situ cancers of the breast, oral cavity, or cervix are eligible).
  2. Prior radiotherapy to the liver or surrounding areas that would result in overlap of radiation therapy fields is an ineligibility criterion. Patients with other known contraindications to radiation including systemic sclerosis, ulcerative colitis etc. also are ineligible.
  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 completion are grounds for exclusion. Patients who received Bevacizumab or other vascular endothelial growth factor antagonists 2 months prior or following TACE/ RT are ineligible. Administration of Anthracyclines or other chemotherapy agents with dominant hepatotoxicity within 8 weeks of completion of RT is also an exclusion criterion.
  4. Severe co-morbidity including (but not restricted to) unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months, transmural myocardial infarction within the last 6 months, uncontrolled arterial hypertension, uncontrolled diabetes mellitus, dementia, acute infections (bacterial, fungal or HIV infection requiring oral or intravenous antibiotics at the time of registration, severe chronic airway disease (COPD) other serious illness requiring hospitalization or precluding study therapy at the time of registration are contraindications.
  5. Patients who are receiving anticoagulation treatment with Coumadin or IV heparin (including anticoagulation to maintain central line) resulting in INR (international normalized ratio) > 2 times upper level normal are ineligible.
  6. Uncontrolled or symptomatic clinical ascites makes patient ineligible for the study.
  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 exposure 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247298

Contacts
Contact: Anna Messer, RN 205-975-2880 amesser@uabmc.edu
Contact: Kristin Webb, BA 205-975-9316 kkwebb@uabmc.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Jolane Gable, RN       jgable@uabmc.edu   
Contact: Kristin K Webb, BA    205-975-9316    kkwebb@uabmc.edu   
Principal Investigator: Rojymon Jacob, MD, FRCP         
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

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01247298     History of Changes
Other Study ID Numbers: F100708009
Study First Received: November 22, 2010
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:
Hepatocellular Carcinoma, HCC, TACE, Radiation Induced Liver Disease (RILD), 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

ClinicalTrials.gov processed this record on July 26, 2014