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Hepatocellular CarcinomaPhase 2NCT00914355

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

A Phase 2 study testing Stereotactic Body Radiation in people with Hepatocellular Carcinoma, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Stereotactic Body Radiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteCanada
Study dates
Aug 2007to 8 Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 19Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University Health Network, Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Stereotactic Body Radiation
Keywords
Hepatocellular Carcinoma, Stereotactic Body Radiation, Unresectable liver cancer, Patients with Hepatocellular Carcinoma
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Body RadiationRadiation

    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.

Study groups in NCT00914355
Study groupRoleWhat they receive
SBRT for Hepatocellular CarcinomaExperimentalNot described
Receives: Radiation: Stereotactic Body Radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine one year local progression free rate, defined as lack of progression within the irradiated volume, using RECIST criteria

    Measured: 5 years

Secondary outcomes (5)

  1. Overall progression free survival

    Measured: 5 years

  2. Overall survival

    Measured: 5 years

  3. Quality of life

    Measured: 5 years

  4. CTC3.0 toxicity

    Measured: 5 years

  5. Cytokine response to radiation and association with complications

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2009 (estimated)
  2. Study startAug 2007
  3. Primary completionAug 2020
  4. Study completion8 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00914355
Sponsor's protocol ID
UHN REB 07-0346-C
Status last verified
Oct 2021
First submitted
4 Jun 2009
Last updated
6 Oct 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Bujold A, Massey CA, Kim JJ, Brierley J, Cho C, Wong RK, Dinniwell RE, Kassam Z, Ringash J, Cummings B, Sykes J, Sherman M, Knox JJ, Dawson LA. Sequential phase I and II trials of stereotactic body radiotherapy for locally advanced hepatocellular carcinoma. J Clin Oncol. 2013 May 1;31(13):1631-9. doi: 10.1200/JCO.2012.44.1659. Epub 2013 Apr 1.

    PubMed 23547075

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stereotactic Body Radiation in people with Hepatocellular Carcinoma, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine one year local progression free rate, defined as lack of progression within the irradiated volume, using RECIST criteria (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00914355, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.

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