Stereotactic Body Radiation Therapy (SBRT) Hepatocellular Carcinoma (COLD 2)

October 4, 2021 updated by: University Health Network, Toronto

Phase II Trial of Stereotactic Body Radiation Therapy for Unresectable Hepatocellular Carcinoma

This study is designed to see whether stereotactic body radiation therapy (SBRT) can reduce tumour size, slow progression of the disease, prolong life and improve quality of life of patients with hepatocellular carcinoma, a cancer of the liver, that cannot be removed surgically (unresectable) and cannot be treated with ablative therapy (e.g. radio-frequency ablation) or trans-arterial chemo-embolization (TACE) therapy (delivery of chemotherapy through an artery that feeds into the liver). SBRT is concentrated focused radiation therapy delivered very precisely to the liver tumour. It is hoped that knowledge obtained from this study will improve our ability to treat patients with liver tumours that cannot be treated with surgery and other methods, and that SBRT may prove to be a treatment that can lead to long-term and permanent control of liver tumours for some patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

From July 2003 to May 2007, over 40 patients with hepatocellular carcinoma participated in two studies at Princess Margaret Hospital (PMH) designed to determine the safety of treating hepatocellular carcinoma with SBRT. These studies have shown that SBRT can be delivered safely to the majority of patients with hepatocellular carcinoma. The treated tumour was controlled (shrank or remained the same size) in 78% of patients at one year following treatment.The median survival of patients was 11 months (i.e. half of patients survived longer and half shorter than 11 months). This survival rate is better than that expected in patients treated with supportive care only (no treatment other than care to make you feel better). Supportive care patients have a median survival rate of 3-9 months. We expect that the benefits of SBRT in this study will be similar to those observed in our initial studies.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network, Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed pathologically, 2)diagnosed by showing vascular enhancement of the lesion on at least two imaging techniques, or 3) diagnosed by showing vascular enhancement on a single technique if the AFP is greater than 200, in the setting of cirrhosis or chronic hepatitis B without cirrhosis (EASL consensus conference guidelines).
  • Either 1) the tumour must be unresectable, based on the opinion of an experienced surgeon specializing in hepatic resection, or 2) the patient Phase II SBRT HCC 13 must be medically inoperable, or 3) extra-hepatic metastases must be present (making hepatic surgery an inappropriate treatment option).
  • Karnofsky performance status (KPS) > 60 (Appendix II)
  • Age: 18 years or older. Both male & female patients of all races can be included in this study. Female patients within reproductive years may not be, nor become, pregnant during participation in this study
  • Patients must have recovered from the effects of previous therapy.
  • Maximal tumor size of 15 cm.

  • Adequate organ function as assessed as follows:

    • Hemoglobin > 90 g/L
    • Absolute neutrophil count > 1.0 bil/L
    • Platelets > 50 bil/L
    • Bilirubin < 4.0 times upper range of normal
    • INR < 1.5 or correctable with vitamin K (unless patient is on coumadin in which case higher levels are acceptable)
    • AST or ALT < 6.0 times upper range of normal
  • Child's A 5-6 liver score or Child B 7-8 liver score, which is only permitted if the maximal tumor size is 10 cm
  • Previous liver resection or ablative therapy is permitted.
  • Life expectancy > 3 months
  • The volume of uninvolved must be at least 700 cc
  • Up to five discrete liver tumors
  • Patients must have signed a study-specific informed consent form. If the patient's mental status precludes this, written informed consent may be given by the patient's legal representative.

Exclusion Criteria:

  • Patients with active hepatitis or encephalopathy related to liver failure
  • Prior radiation therapy to the right upper abdomen, precluding reirradiation of the liver. That is, any previous radiation therapy in which a mean dose to the liver of 15 Gy in conventional fractionation was delivered, or previous doses to critical normal structures that would make re-irradiation unsafe. The PI should be called if there is any question of safety of re-irradiation.
  • Eligible for RFA or alcohol ablation
  • Eligible for TACE
  • Prior uncontrolled, life threatening malignancy within the six months.
  • Pregnancy is not permitted, and in women of child bearing age, a pregnancy test and acceptable methods of contraception are warranted.
  • Previous gastric, duodenal or variceal bleed within the past 2 months.
  • Commencement of coumadin use within the past 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SBRT for Hepatocellular Carcinoma
Radiation: Stereotactic Body Radiation
Radiation therapy will be delivered on six occasions, over two weeks. Each treatment will take approximately 30 minutes to deliver.You may be asked to swallow 250 cc of oral contrast before each radiation therapy treatment.Pepto Bismol (a liquid that coats the stomach and is used to treat heartburn) and/or water may be combined with the contrast to improve the quality of the stomach's image.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine one year local progression free rate, defined as lack of progression within the irradiated volume, using RECIST criteria
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years
Quality of life
Time Frame: 5 years
5 years
Overall progression free survival
Time Frame: 5 years
5 years
CTC3.0 toxicity
Time Frame: 5 years
5 years
Cytokine response to radiation and association with complications
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Princess Margaret Hospital, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

August 1, 2020

Study Completion (ACTUAL)

December 8, 2020

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 4, 2009

First Posted (ESTIMATE)

June 5, 2009

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN REB 07-0346-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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