Liver NeoplasmsPhase 1/2NCT00152906
Stereotactic Radiotherapy (SRT) Liver (COLD 1)
A Phase 1/2 study testing Stereotactic radiotherapy (SRT) or highly conformal (CRT) in people with Liver Neoplasms and Neoplasm Metastases, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
A minority of patients with colorectal liver metastases and hepatobiliary cancer (primary liver cancer) are candidates for surgery, but there are no curative treatment options for these patients. Their median survival time is 3 to 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms, Neoplasm Metastases
- What is being tested?
- Stereotactic radiotherapy (SRT) or highly conformal (CRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2003to 10 Jul 2020
- Phase
- Phase 1/2
- 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
- Primary hepatobiliary confirmed pathologically or via imaging
- Liver metastases from colorectal cancer or other solid malignancy, confirmed pathologically
- New radiographic liver lesions most consistent with metastases, in a patient with previously pathologically proven solid malignancy and a previously negative liver contrast CT or MRI
- The tumor must be unresectable or the patient must be medically inoperable or extra-hepatic metastases must be present
- Karnofsky performance status (KPS) > 60
- Age > 18 years
Show all 14Show fewer
- Patients must have recovered from the effects of previous surgery, radiotherapy or chemotherapy
- Chemotherapy must be completed at least 2 weeks prior to radiation therapy or not planned to be administered for at least 2 weeks
- Adequate organ function as assessed as follows:Hemoglobin > 90 g/L, Absolute neutrophil count > 1.5 bil/L, Platelets > 80,000 bil/L, Bilirubin < 3.0 times upper range of normal, INR < 1.3 or correctable with vitamin K, AST or ALT < 6.0 times upper range of normal, Creatinine < 200 umol/L (other than patients who are having dialysis or already have dialysis lines in place for future dialysis for renal failure. These patients may be treated on study with no upper limit on their creatinine.)
- Child A liver score
- Previous liver resection or ablative therapy is permitted.
- Life expectancy > 3 months
- Multiple metastases are permitted (volume of uninvolved must be at least 800 cc, and the maximal effective liver volume that may be treated is 80%.
- Informed consent form
Who cannot join
- Patients with active hepatitis or clinically significant liver failure
- Prior radiation therapy to the right upper abdomen, precluding re-irradiation of the liver. (Prior pelvic radiation is permitted, as long as no overlap between pelvic and liver radiation fields occurs.)
- Prior uncontrolled, life threatening malignancy within the past year.
- Gross (clinically apparent) ascites.
- Pregnancy is not permitted, and in women of child bearing age, a pregnancy test and birth control are warranted.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Trial of Highly Conformal Radiotherapy for Unresectable Liver Metastases and Hepatobiliary Carcinoma
A minority of patients with colorectal liver metastases and hepatobiliary cancer (primary liver cancer) are candidates for surgery, but there are no curative treatment options for these patients. Their median survival time is 3 to 12 months. Stereotactic radiation (SRT) (highly conformal radiotherapy (CRT)) is a treatment option for these patients with unresectable liver cancer, now possible due to improvements in our ability to localize and immobilize liver tumors and an improved understanding of the partial liver volume tolerance to radiation. SRT should permit liver tumors to be treated to tumorcidal doses while sparing the uninvolved liver, decreasing the risk of treatment related normal tissue toxicity. With such conformal radiation, it is possible to deliver radiation in fewer fractions than traditionally required, which should be more convenient for patients. In this study, CRT will be delivered during shallow breathing or breath hold to minimize organ motion due to breathing, decreasing the volume of normal liver that must be irradiated.
- Conditions
- Liver Neoplasms, Neoplasm Metastases
- Being tested
- Stereotactic radiotherapy (SRT) or highly conformal (CRT)
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiotherapy (SRT) or highly conformal (CRT)Procedure or surgery
SRT or CRT is radiation delivered precisely conforming the high dose region to the tumor, usually in a few highdose fractions.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic RT or highly conformal RT | Experimental | Not described Receives: Procedure: Stereotactic radiotherapy (SRT) or highly conformal (CRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: To evaluate feasibility and maximally tolerated dose of SRT
Measured: assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years
Phase II: To determine with more confidence the rate and spectrum of all toxicities that occur at the maximally tolerated dose of radiation.
Measured: assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years
Secondary outcomes (6)
To evaluate local control, progression-free survival and survival of patients with unresectable primary hepatobiliary cancer and metastatic liver cancer treated with SRT.
Measured: assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years
To evaluate the quality of life.
Measured: assessment: pre-treatement, 1, 3, 6,12 months post
To evaluate changes in liver function following SRT.
Measured: 3 to 12 months
To evaluate patterns of breathing at and during RT.
Measured: during radiation treatment only
To develop more confidence in a revised normal tissue complication probability (NTCP) model for radiation induced liver toxicity and collect preliminary data to determine how the liver responds to radiation.
Measured: at 3 months post RT
To determine whether serum cytokines and P-III-P can help predict RILD.
Measured: baseline, during radiation and up to 3 months post radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionJul 2016
- Study completion10 Jul 2020
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 Liver NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Responsible party
- Sponsor
- Investigators
- Laura Dawson, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152906
- Sponsor's protocol ID
- UHN REB 03-0295-C
- Other IDs
- ASCO Clinical Research Grant
- Status last verified
- Aug 2020
- First submitted
- 8 Sep 2005
- Last updated
- 14 Aug 2020
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Highly Conformal Radiotherapy for Unresectable Liver Metastases and Hepatobiliary Carcinoma
- ClinicalTrials.gov ID
- NCT00152906
- Acronym / sponsor ID
- UHN REB 03-0295-C
- Conditions
- Liver Neoplasms, Neoplasm Metastases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Study start
- Jul 2003
- Primary completion
- Jul 2016 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 9 Sep 2005 (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.
A minority of patients with colorectal liver metastases and hepatobiliary cancer (primary liver cancer) are candidates for surgery, but there are no curative treatment options for these patients. Their median survival time is 3 to 12 months. Stereotactic radiation (SRT) (highly conformal radiotherapy (CRT)) is a treatment option for these patients with unresectable liver cancer, now possible due to improvements in our ability to localize and immobilize liver tumors and an improved understanding of the partial liver volume tolerance to radiation. SRT should permit liver tumors to be treated to tumorcidal doses while sparing the uninvolved liver, decreasing the risk of treatment related normal tissue toxicity. With such conformal radiation, it is possible to deliver radiation in fewer fractions than traditionally required, which should be more convenient for patients. In this study, CRT will be delivered during shallow breathing or breath hold to minimize organ motion due to breathing, decreasing the volume of normal liver that must be irradiated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic RT or highly conformal RT | Experimental | Procedure: Stereotactic radiotherapy (SRT) or highly conformal (CRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Primary hepatobiliary confirmed pathologically or via imaging
- Liver metastases from colorectal cancer or other solid malignancy, confirmed pathologically
- New radiographic liver lesions most consistent with metastases, in a patient with previously pathologically proven solid malignancy and a previously negative liver contrast CT or MRI
- The tumor must be unresectable or the patient must be medically inoperable or extra-hepatic metastases must be present
- Karnofsky performance status (KPS) > 60
Key exclusion criteria (5 listed)
- Patients with active hepatitis or clinically significant liver failure
- Prior radiation therapy to the right upper abdomen, precluding re-irradiation of the liver. (Prior pelvic radiation is permitted, as long as no overlap between pelvic and liver radiation fields occurs.)
- Prior uncontrolled, life threatening malignancy within the past year.
- Gross (clinically apparent) ascites.
- Pregnancy is not permitted, and in women of child bearing age, a pregnancy test and birth control are warranted.
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 radiotherapy (SRT) or highly conformal (CRT)SRT or CRT is radiation delivered precisely conforming the high dose region to the tumor, usually in a few highdose fractions. | Procedure or surgery | Stereotactic RT or highly conformal RT |
Primary outcome
Phase I: To evaluate feasibility and maximally tolerated dose of SRT
Time frame: assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years
Phase II: To determine with more confidence the rate and spectrum of all toxicities that occur at the maximally tolerated dose of radiation.
Time frame: assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years
6 secondary outcomes
To evaluate local control, progression-free survival and survival of patients with unresectable primary hepatobiliary cancer and metastatic liver cancer treated with SRT.
Time frame: assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years
To evaluate the quality of life.
Time frame: assessment: pre-treatement, 1, 3, 6,12 months post
To evaluate changes in liver function following SRT.
Time frame: 3 to 12 months
To evaluate patterns of breathing at and during RT.
Time frame: during radiation treatment only
To develop more confidence in a revised normal tissue complication probability (NTCP) model for radiation induced liver toxicity and collect preliminary data to determine how the liver responds to radiation.
Time frame: at 3 months post RT
To determine whether serum cytokines and P-III-P can help predict RILD.
Time frame: baseline, during radiation and up to 3 months post radiation
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 14 Aug 2020.
- Derived from this study: PubMed 23547075Bujold 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.
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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
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stereotactic radiotherapy (SRT) or highly conformal (CRT) in people with Liver Neoplasms and Neoplasm Metastases, 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 14 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 14 Aug 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Phase I: To evaluate feasibility and maximally tolerated dose of SRT (time frame: assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years). The study lists 2 primary outcomes in all. 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 NCT00152906, 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 14 Aug 2020.