Hepatocellular CarcinomaPhase 2NCT00923897
Palliative Radiotherapy (RT) for Liver Metastases (Mets) and Hepatocellular Carcinoma (HCC)(COLD 4)
A Phase 2 study testing Palliative RT in people with Hepatocellular Carcinoma and Hepatic Metastasis, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Palliative radiotherapy is radiation treatment given to help reduce pain or discomfort, or other symptoms related to cancer. This is used commonly for cancer that has spread to the bones and brain, and for many other primary cancers that are too advanced to be cured, including lung cancer, pancreatic cancer and head… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatic Metastasis
- What is being tested?
- Palliative RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2007to 26 Sep 2018
- 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
- Patients with hepatocellular carcinoma or hepatic metastases from a solid malignancy, unsuitable for radical therapy (including resection, transplant, conformal high dose radiotherapy), confirmed by biopsy or imaging
- Symptoms of hepatic pain, discomfort, nausea, or fatigue requiring palliation
- KPS>60
- Expected survival of greater than 3 months
- Platelet count > 25 bil/L, Hemoglobin > 70 g/L, INR<3, Bilirubin<100 umol/L, AST < 350 U/L or ALT< 400 U/L
- Have signed an informed consent form approved by the Research Ethics Board (REB) at Princess Margaret Hospital
Who cannot join
- Chemotherapy or novel drug within the past 2 weeks
- TACE(transarterial chemoembolization)within the past 1 month
- Plan for active treatment of the hepatocellular carcinoma or hepatic metastases, including TACE or RFA or ETOH injection
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and Hepatic Metastases
Palliative radiotherapy is radiation treatment given to help reduce pain or discomfort, or other symptoms related to cancer. This is used commonly for cancer that has spread to the bones and brain, and for many other primary cancers that are too advanced to be cured, including lung cancer, pancreatic cancer and head and neck cancer. The benefits of palliative radiotherapy for advanced liver cancer have not been well studied.
This study is designed to help to see whether palliative radiation therapy is effective in controlling pain, discomfort or other symptoms related to liver cancer, and how this therapy Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and Hepatic Metastases might affect the quality of life of patients receiving such therapy. This information will help the doctors understand if there are specific conditions under which radiation therapy is more effective and worthwhile, and how it may affect the quality of life for patients who have locally advanced hepatocellular carcinoma and hepatic metastasis.
Read the detailed description
The liver is one of the most common sites with tumour involvement, including both primary and metastatic disease. Gastrointestinal tumours, breast, lung and melanoma are the most common primary sites for hepatic metastases. Hepatocellular carcinoma(HCC) is the sixth most common cancer worldwide, with over 600,000 new cases diagnosed per year. It is the third most common cause of cancer related death.Although, predominately a disease in Asia and sub-Saharan Africa, the incidence of HCC is increasing in North America. The use of radiation in unresectable hepatocellular carcinomas, as well as hepatic metastases, for palliation is uncommon in clinical practice.
This may be because there is a prevailing perception that radiation to the liver will inevitably lead to radiation induced liver disease (RILD). However, several single institution, predominantly retrospective studies, have demonstrated effective palliation for locally advanced HCC as well as hepatic metastases with minimal toxicity.In this study, palliative radiotherapy (RT), delivered in one fraction of 8Gy, will be given to symptomatic patients who are not candidates for radical treatment. We hypothesize that palliative RT will provide symptomatic relief to a large fraction of the patients, with both primary and metastatic disease. We also expect minimal toxicities at this treatment dose.
- Conditions
- Hepatocellular Carcinoma, Hepatic Metastasis
- Being tested
- Palliative RT
- Keywords
- Hepatocellular Carcinoma, Hepatic Metastasis, Palliative Radiation Therapy, Locally advanced HCC and Hepatic Metastasis
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative RTRadiation
Prior to receiving radiation treatment, it is recommended that you take medications to reduce the chance of nausea related to therapy. The treatment will take approximately 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| RT for Liver Mets and HCC | Experimental | Not described Receives: Radiation: Palliative RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the change in index symptom(s) using an 11 point numerical rating scale for patients with locally advanced hepatocellular cancer or hepatic metastases treated with 8Gy
Measured: 5 years
Secondary outcomes (4)
Determine the change in EORTC QLQ-C30 & FACT-Hep for patients with locally advanced HCC/hepatic metastases treated w/h 8Gy and assess the toxicity of treatment using CTC AE v3.0 toxicity score
Measured: 5 years
To measure changes in serum cytokines and proteomics following radiotherapy.
Measured: 5 years
To determine the feasibility of Cone Beam CT for simulation and treatment and optimize image quality offline.
Measured: 5 years
To determine serum marker and radiographic response with 8Gy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startFeb 2007
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Laura Dawson, MD, Principal investigator, University Health Network, Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923897
- Sponsor's protocol ID
- UHN REB 07-0020-CE
- Status last verified
- Jun 2019
- First submitted
- 16 Jun 2009
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Soliman H, Ringash J, Jiang H, Singh K, Kim J, Dinniwell R, Brade A, Wong R, Brierley J, Cummings B, Zimmermann C, Dawson LA. Phase II trial of palliative radiotherapy for hepatocellular carcinoma and liver metastases. J Clin Oncol. 2013 Nov 1;31(31):3980-6. doi: 10.1200/JCO.2013.49.9202. Epub 2013 Sep 23.
PubMed 24062394
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and Hepatic Metastases
- ClinicalTrials.gov ID
- NCT00923897
- Acronym / sponsor ID
- UHN REB 07-0020-CE
- Conditions
- Hepatocellular Carcinoma, Hepatic Metastasis
- Keywords
- Hepatocellular Carcinoma, Hepatic Metastasis, Palliative Radiation Therapy, Locally advanced HCC and Hepatic Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Feb 2007
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Palliative radiotherapy is radiation treatment given to help reduce pain or discomfort, or other symptoms related to cancer. This is used commonly for cancer that has spread to the bones and brain, and for many other primary cancers that are too advanced to be cured, including lung cancer, pancreatic cancer and head and neck cancer. The benefits of palliative radiotherapy for advanced liver cancer have not been well studied.
This study is designed to help to see whether palliative radiation therapy is effective in controlling pain, discomfort or other symptoms related to liver cancer, and how this therapy Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and Hepatic Metastases might affect the quality of life of patients receiving such therapy. This information will help the doctors understand if there are specific conditions under which radiation therapy is more effective and worthwhile, and how it may affect the quality of life for patients who have locally advanced hepatocellular carcinoma and hepatic metastasis.
Detailed description
The liver is one of the most common sites with tumour involvement, including both primary and metastatic disease. Gastrointestinal tumours, breast, lung and melanoma are the most common primary sites for hepatic metastases. Hepatocellular carcinoma(HCC) is the sixth most common cancer worldwide, with over 600,000 new cases diagnosed per year. It is the third most common cause of cancer related death.Although, predominately a disease in Asia and sub-Saharan Africa, the incidence of HCC is increasing in North America. The use of radiation in unresectable hepatocellular carcinomas, as well as hepatic metastases, for palliation is uncommon in clinical practice.
This may be because there is a prevailing perception that radiation to the liver will inevitably lead to radiation induced liver disease (RILD). However, several single institution, predominantly retrospective studies, have demonstrated effective palliation for locally advanced HCC as well as hepatic metastases with minimal toxicity.In this study, palliative radiotherapy (RT), delivered in one fraction of 8Gy, will be given to symptomatic patients who are not candidates for radical treatment. We hypothesize that palliative RT will provide symptomatic relief to a large fraction of the patients, with both primary and metastatic disease. We also expect minimal toxicities at this treatment dose.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RT for Liver Mets and HCC | Experimental | Radiation: Palliative RT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with hepatocellular carcinoma or hepatic metastases from a solid malignancy, unsuitable for radical therapy (including resection, transplant, conformal high dose radiotherapy), confirmed by biopsy or imaging
- Symptoms of hepatic pain, discomfort, nausea, or fatigue requiring palliation
- KPS>60
- Expected survival of greater than 3 months
- Platelet count > 25 bil/L, Hemoglobin > 70 g/L, INR<3, Bilirubin<100 umol/L, AST < 350 U/L or ALT< 400 U/L
Key exclusion criteria (3 listed)
- Chemotherapy or novel drug within the past 2 weeks
- TACE(transarterial chemoembolization)within the past 1 month
- Plan for active treatment of the hepatocellular carcinoma or hepatic metastases, including TACE or RFA or ETOH injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative RTPrior to receiving radiation treatment, it is recommended that you take medications to reduce the chance of nausea related to therapy. The treatment will take approximately 30 minutes. | Radiation | RT for Liver Mets and HCC |
Primary outcome
To determine the change in index symptom(s) using an 11 point numerical rating scale for patients with locally advanced hepatocellular cancer or hepatic metastases treated with 8Gy
Time frame: 5 years
4 secondary outcomes
Determine the change in EORTC QLQ-C30 & FACT-Hep for patients with locally advanced HCC/hepatic metastases treated w/h 8Gy and assess the toxicity of treatment using CTC AE v3.0 toxicity score
Time frame: 5 years
To measure changes in serum cytokines and proteomics following radiotherapy.
Time frame: 5 years
To determine the feasibility of Cone Beam CT for simulation and treatment and optimize image quality offline.
Time frame: 5 years
To determine serum marker and radiographic response with 8Gy
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Derived from this study: PubMed 24062394Soliman H, Ringash J, Jiang H, Singh K, Kim J, Dinniwell R, Brade A, Wong R, Brierley J, Cummings B, Zimmermann C, Dawson LA. Phase II trial of palliative radiotherapy for hepatocellular carcinoma and liver metastases. J Clin Oncol. 2013 Nov 1;31(31):3980-6. doi: 10.1200/JCO.2013.49.9202. Epub 2013 Sep 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Dawson, MD principal investigator
University Health Network, Princess Margaret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palliative RT in people with Hepatocellular Carcinoma and Hepatic Metastasis, 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 6 inclusion and 3 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 18 Jun 2019. 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?
To determine the change in index symptom(s) using an 11 point numerical rating scale for patients with locally advanced hepatocellular cancer or hepatic metastases treated with 8Gy (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 NCT00923897, 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 18 Jun 2019.