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

NCT01247298 | Completed Early Phase 1 Results DMC

• 1 other identifier: F100708009
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Hepatocellular Carcinoma (HCC); Trans-Arterial Chemobolizaion (TACE); Radiation Induced Liver Disease (RILD); Stereotactic Body Radiation Therapy (SBRT)

Outcome Measures

Primary Outcomes (3)

• Safety of a Combination Therapy

  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.

  Baseline to 45 day after completing combination treatment.

• Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT.

  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.

  Baseline to up to 2 years after treatment completed

• Local Recurrence Rate

  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.

  Baseline to up to 2 years after treatment completed

Secondary Outcomes (2)

• Percentage of Participants With Overall Survival

  up to 2 years after treatment completed

• Percentage of Participants With Local Failure Patterns

  Baseline up to 2 years after treatment completed

Study Arms (1)

Stereotactic Body Radiation Therapy (SBRT)

EXPERIMENTAL

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)

Interventions

Stereotactic Body Radiation Therapy (SBRT) COMBINATION_PRODUCT

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.

Also known as: TACE

Stereotactic Body Radiation Therapy (SBRT)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients presenting with any of the following will not be included in the study:
• Prior invasive malignancies
• Prior radiotherapy to the liver or surrounding areas.
• 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
• Severe medical co-morbidities
• INR (international normalized ratio) \> 2 times upper level normal
• Uncontrolled or symptomatic clinical ascites
• Major surgical procedure within 3 weeks prior to study entry.
• History of hypersensitivity to chemotherapy agents, contrast material.
• Pregnancy, breast-feeding or planning to become pregnant.
• Treatment with any investigational product in the last 4 weeks before study entry.
• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Rojymon Jacob, MD
• Organization: University of Alabama at Birmingham (UAB)

rjacob@uabmc.edu

205-975-9704

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 24, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 21, 2017
• Results First Posted: June 19, 2017

Record last verified: 2017-07

Locations

US (1)