Colorectal CancerPhase 2NCT00511862
TheraSphere for the Treatment of Liver Metastases
A Phase 2 study testing Yttrium 90 glass microspheres in people with Colorectal Cancer and Carcinoma, Neuroendocrine, run by Boston Scientific Corporation at 5 sites in United States.
Trial summary
This study will evaluate Liver Progression Free Survival (PFS) and safety of TheraSphere treatment at doses of 120 Gy +/1 10% in patients at least 18 years of age diagnosed with metastatic disease to the liver that cannot be treated or is progressing following treatment with systemic or other liver-directed therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Carcinoma, Neuroendocrine, Neoplasm Metastasis
- What is being tested?
- Yttrium 90 glass microspheres
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2007to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years of age or older
- diagnosis of metastatic disease to the liver that is refractory to, or inappropriate for, other systemic or liver-directed therapies
- unresectable liver metastases
- target tumors measurable using standard imaging techniques
- tumor replacement < or = 50% of total liver volume (visual estimation by investigator)
- Hypervascular tumors (visual estimation by investigator)
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- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- minimum one month since most recent prior cancer therapy with the exception of patients receiving Sandostatin for neuroendocrine cancer
- patient informed consent
Who cannot join
- At risk of hepatic or renal failure within 21 days of treatment (serum creatinine > 2.0 mg/dL unless on dialysis; serum bilirubin ≥ 2.0 mg/dL; albumin < 2.0 mg/dL or any history of hepatic encephalopathy)
- contraindications to angiography and selective visceral catheterization including any non-correctable bleeding diathesis or coagulopathy, severe peripheral vascular disease or history of non-management allergy or intolerance to contrast, narcotics, sedatives or atropine
- severe liver dysfunction or presentation of pulmonary insufficiency or clinically evident history of chronic obstructive pulmonary disease
- cirrhosis or portal hypertension
- prior external beam radiation treatment to the liver
- prior TheraSphere treatment to the liver
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- any intervention for, or compromise of the Ampulla of Vater
- clinically evident ascites (trace ascites on imaging is acceptable)
- any continuing complications of prior cancer therapy that have not improved or resolved prior to 21 days before first TheraSphere treatment
- significant life-threatening extrahepatic disease in judgment of physician
- concurrent enrollment in another study
- alternative available therapies in judgement of physician
- evidence on technetium-99m macroaggregated albumin scan that shows lung shunting > 30 Gy cumulative limit
- evidence on technetium-99m macroaggregated albumin scan showing potential for deposition of microspheres to the gastrointestinal tract that cannot be eliminated by catheter placement or corrective action using standard angiographic techniques
- positive serum pregnancy test in women of childbearing potential
- co-morbid disease or condition that puts the patient at undue risk or precludes use of TheraSphere in judgment of physician
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Albany Medical Center
Albany, New York, 12208
John Hopkins Hospital
Baltimore, Maryland, 21287-4010
Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611-2927
Medical College of Wisconsin, Froedtert Hospital
Milwaukee, Wisconsin, 53226
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: TheraSphere for the Treatment of Liver Metastases: An Open Label Trial of TheraSphere in Patients With Liver Metastases From Primary Colorectal Cancer, Neuroendocrine Cancer or Non-colorectal/Non-neuroendocrine Cancer
This study will evaluate Liver Progression Free Survival (PFS) and safety of TheraSphere treatment at doses of 120 Gy +/1 10% in patients at least 18 years of age diagnosed with metastatic disease to the liver that cannot be treated or is progressing following treatment with systemic or other liver-directed therapies.
- Being tested
- Yttrium 90 glass microspheres
- Keywords
- TheraSphere, radioactive microspheres, Yttrium-90, Yttrium glass microspheres
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Neuroendocrine, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yttrium 90 glass microspheresDevice
Also called TheraSphere
120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe
| Study group | Role | What they receive |
|---|---|---|
| TheraSphere | Experimental | Single arm, TheraSphere Yttrium 90 glass microspheres at 120 Gy +/- 10%; stratified by type of disease (colorectal cancer, neuroendocrine cancer, non-colorectal/non-neuroendocrine cancer Receives: Device: Yttrium 90 glass microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)
Progression per RECIST v 1.0 is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. A maximum of 5 target lesions per organ are assessed. To assess the impact of a non-systemic local therapy on progression, for the purposes of this trial, hepatic progression was defined as at least a 20% increase in the sum of the longest diameter of target hepatic lesions. Hepatic progression-free survival is the time from the day of first treatment with TheraSphere to determination of hepatic progression.
Measured: From the date of first treatment until date of first documented progression; median patient follow-up 30 months
Secondary outcomes (1)
Overall Survival
Duration of survival from date of first TheraSphere treatment to date of death or censored to last known date alive.
Measured: Time from first TheraSphere treatment to death; median follow up 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startJan 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BTG International Inc.
- Responsible party
- Sponsor
- Investigators
- Al Benson III, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511862
- Sponsor's protocol ID
- G040148
- Status last verified
- Apr 2021
- First submitted
- 2 Aug 2007
- Last updated
- 13 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TheraSphere for the Treatment of Liver Metastases: An Open Label Trial of TheraSphere in Patients With Liver Metastases From Primary Colorectal Cancer, Neuroendocrine Cancer or Non-colorectal/Non-neuroendocrine Cancer
- ClinicalTrials.gov ID
- NCT00511862
- Acronym / sponsor ID
- G040148
- Keywords
- TheraSphere, radioactive microspheres, Yttrium-90, Yttrium glass microspheres
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- BTG International Inc.
- Study start
- Jan 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 Aug 2007 (estimated)
- Results
- Posted 23 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate Liver Progression Free Survival (PFS) and safety of TheraSphere treatment at doses of 120 Gy +/1 10% in patients at least 18 years of age diagnosed with metastatic disease to the liver that cannot be treated or is progressing following treatment with systemic or other liver-directed therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TheraSphere | Experimental | Device: Yttrium 90 glass microspheresSingle arm, TheraSphere Yttrium 90 glass microspheres at 120 Gy +/- 10%; stratified by type of disease (colorectal cancer, neuroendocrine cancer, non-colorectal/non-neuroendocrine cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older
- diagnosis of metastatic disease to the liver that is refractory to, or inappropriate for, other systemic or liver-directed therapies
- unresectable liver metastases
- target tumors measurable using standard imaging techniques
- tumor replacement < or = 50% of total liver volume (visual estimation by investigator)
Key exclusion criteria (16 listed)
- At risk of hepatic or renal failure within 21 days of treatment (serum creatinine > 2.0 mg/dL unless on dialysis; serum bilirubin ≥ 2.0 mg/dL; albumin < 2.0 mg/dL or any history of hepatic encephalopathy)
- contraindications to angiography and selective visceral catheterization including any non-correctable bleeding diathesis or coagulopathy, severe peripheral vascular disease or history of non-management allergy or intolerance to contrast, narcotics, sedatives or atropine
- severe liver dysfunction or presentation of pulmonary insufficiency or clinically evident history of chronic obstructive pulmonary disease
- cirrhosis or portal hypertension
- prior external beam radiation treatment to the liver
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 |
|---|---|---|
| Yttrium 90 glass microspheresAlso: TheraSphere120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe | Device | TheraSphere |
Primary outcome
Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)
Time frame: From the date of first treatment until date of first documented progression; median patient follow-up 30 months
Progression per RECIST v 1.0 is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. A maximum of 5 target lesions per organ are assessed. To assess the impact of a non-systemic local therapy on progression, for the purposes of this trial, hepatic progression was defined as at least a 20% increase in the sum of the longest diameter of target hepatic lesions. Hepatic progression-free survival is the time from the day of first treatment with TheraSphere to determination of hepatic progression.
1 secondary outcome
Overall Survival
Time frame: Time from first TheraSphere treatment to death; median follow up 30 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Al Benson III, MD principal investigator
Northwestern University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yttrium 90 glass microspheres in people with Colorectal Cancer and Carcinoma, Neuroendocrine, run by Boston Scientific Corporation at 5 sites in United States.
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 9 inclusion and 16 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 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Yes. Results are posted in the registry (first posted 23 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST) (time frame: From the date of first treatment until date of first documented progression; median patient follow-up 30 months). 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 13 May 2021.