Liver MetastasisPhase 2NCT00914615
Stereotactic Body Radiation Therapy (SBRT) in Liver Metastasis (COLD 3)
A Phase 2 study testing Stereotactic Body Radiation in people with Liver Metastasis, run by University Health Network, Toronto at 1 site in Canada.
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. SBRT is concentrated focused radiation therapy delivered very precisely to the liver tumour. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastasis
- What is being tested?
- Stereotactic Body Radiation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2007to 7 Aug 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
- Eligible patients must have liver metastases from colorectal cancer 1) with histologic confirmation of metastases, 2) histologic confirmation of primary cancer and multiple new enhancing lesions in the liver consistent with metastases, or 3) histologic confirmation of primary cancer and a growing enhancing lesion in the liver Phase II SBRT Mets 13 consistent with a metastases
- Either 1) the tumour must be unresectable, based on the opinion of an experienced surgeon specializing in hepatic resection, or 2) the patient 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
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- Adequate organ function as assessed as follows:
- Hemoglobin > 90 g/L
- Absolute neutrophil count > 1.0 bil/L
- Platelets > 60bil/L
- Bilirubin < 4.0 times upper range of normal
- INR < 1.5 or correctable with vitamin K (unless patients are on anticoagulation doses that have been stable for the past 2 months and they haven't had a bleed in the past 2 months)
- AST or ALT < 6.0 times upper limit of normal range
- Child's A 5-6 liver score
- 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.
- 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 variceal bleed within the past 2 months
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 Stereotactic Body Radiation Therapy for Unresectable Liver Metastases From Colorectal 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. SBRT is concentrated focused radiation therapy delivered very precisely to the liver tumour.
Presently, the treatment for unresectable liver metastases from colorectal cancer is most often chemotherapy or novel targeted therapy. These treatments may improve survival, but not control the metastases permanently; so new treatments are needed to control metastases. 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 50 patients with liver metastases participated in two studies at Princess Margaret Hospital (PMH) designed to determine the safety of treating liver metastases with SBRT. These studies have shown that SBRT can be delivered safely to the majority of patients with liver metastases. The treated tumour was controlled (shrank or remained the same size) in 74% of patients at one year following treatment. The median survival of patients was 16 months (i.e.half of patients survived longer and half shorter than 16 months). This survival rate is better than that expected in patients whose tumours grew bigger even though they were treated with chemotherapy. Supportive care only (no treatment other than care to make you feel better) in these patients is associated with a median survival rate of 6-12 months. We expect that the benefits of SBRT in this study will be similar to those observed in our initial studies.
- Conditions
- Liver Metastasis
- Being tested
- Stereotactic Body Radiation
- Keywords
- Stereotactic Body Radiation Therapy, Liver Metastasis from colorectal cancer, Patients with Liver Metastasis
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 (up to an hour including all imaging and set-up procedures). 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 group | Role | What they receive |
|---|---|---|
| SBRT for liver mets from colorectal cancer | Experimental | Not described Receives: Radiation: Stereotactic Body Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Overall progression free survival
Measured: 5 years
Overall survival
Measured: 5 years
Quality of life
Measured: 5 years
CTC3.0 toxicity
Measured: 5 years
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.
- First posted5 Jun 2009 (estimated)
- Study startAug 2007
- Primary completion16 Aug 2019
- Study completion7 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Dawson, MD, Principal investigator, University Health Network, Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914615
- Sponsor's protocol ID
- UHN REB 07-0348-C
- Status last verified
- Oct 2021
- First submitted
- 4 Jun 2009
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Stereotactic Body Radiation Therapy for Unresectable Liver Metastases From Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00914615
- Acronym / sponsor ID
- UHN REB 07-0348-C
- Conditions
- Liver Metastasis
- Keywords
- Stereotactic Body Radiation Therapy, Liver Metastasis from colorectal cancer, Patients with Liver Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2007 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 5 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.
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. SBRT is concentrated focused radiation therapy delivered very precisely to the liver tumour.
Presently, the treatment for unresectable liver metastases from colorectal cancer is most often chemotherapy or novel targeted therapy. These treatments may improve survival, but not control the metastases permanently; so new treatments are needed to control metastases. 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.
Detailed description
From July 2003 to May 2007, over 50 patients with liver metastases participated in two studies at Princess Margaret Hospital (PMH) designed to determine the safety of treating liver metastases with SBRT. These studies have shown that SBRT can be delivered safely to the majority of patients with liver metastases. The treated tumour was controlled (shrank or remained the same size) in 74% of patients at one year following treatment. The median survival of patients was 16 months (i.e.half of patients survived longer and half shorter than 16 months). This survival rate is better than that expected in patients whose tumours grew bigger even though they were treated with chemotherapy. Supportive care only (no treatment other than care to make you feel better) in these patients is associated with a median survival rate of 6-12 months. We expect that the benefits of SBRT in this study will be similar to those observed in our initial studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT for liver mets from colorectal cancer | Experimental | Radiation: Stereotactic Body Radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Eligible patients must have liver metastases from colorectal cancer 1) with histologic confirmation of metastases, 2) histologic confirmation of primary cancer and multiple new enhancing lesions in the liver consistent with metastases, or 3) histologic confirmation of primary cancer and a growing enhancing lesion in the liver Phase II SBRT Mets 13 consistent with a metastases
- Either 1) the tumour must be unresectable, based on the opinion of an experienced surgeon specializing in hepatic resection, or 2) the patient 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
Key exclusion criteria (5 listed)
- 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.
- 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 variceal bleed within the past 2 months
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 |
|---|---|---|
| Stereotactic Body RadiationRadiation therapy will be delivered on six occasions, over two weeks. Each treatment will take approximately 30 minutes to deliver (up to an hour including all imaging and set-up procedures). 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. | Radiation | SBRT for liver mets from colorectal cancer |
Primary outcome
Determine one year local progression free rate, defined as lack of progression within the irradiated volume, using RECIST criteria.
Time frame: 5 years
5 secondary outcomes
Overall progression free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Quality of life
Time frame: 5 years
CTC3.0 toxicity
Time frame: 5 years
Cytokine response to radiation and association with complications
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 6 Oct 2021.
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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 Stereotactic Body Radiation in people with Liver 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 19 inclusion and 5 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?
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.