Liver CancerNCT00532740
Radiolabeled Glass Beads in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
An observational study of Liver Cancer and Metastatic Cancer, run by Northwestern University at 1 site in United States.
Trial summary
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Metastatic Cancer
- What is being tested?
- Yttrium Y 90 glass microspheres
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to 16 Mar 2022
- Phase
- Observational
- 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
Study population: Patients with metastatic cancer of the liver who are not surgical resection candidates.
DISEASE CHARACTERISTICS:
- Confirmed diagnosis of metastatic intrahepatic carcinoma
- Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass AND known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP
- Unresectable disease
- No portal hypertension with portal venous shunt away from the liver
- FDA approval to receive compassionate use of yttrium Y 90 glass microspheres
- No significant extrahepatic disease representing an imminent life-threatening outcome
- No evidence of potential delivery of > 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either of the following:
- First administration of yttrium Y 90 glass microspheres (TheraSphere ®)
- Cumulative delivery of radiotherapy to the lungs over multiple treatments
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Absolute granulocyte count ≥ 1,500/µL
- Platelet count ≥ 25,000/μL
- Creatinine ≤ 2.0 mg/dL (unless using non-iodinated contrast or on dialysis)
- Serum bilirubin ≤ 3.0 mg/dL (in some cases where there is an elevated bilirubin, and the tumor may be isolated from a vascular standpoint, treatment may proceed)
- No contraindication to angiography or selective visceral catheterization, including any of the following:
- History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, that cannot be controlled using basic angiographic techniques
- Bleeding diathesis, not correctable by usual forms of therapy
- Severe peripheral vascular disease that would preclude catheterization
- No severe liver dysfunction or pulmonary insufficiency
- No active uncontrolled infection
- No significant underlying medical or psychiatric illness
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No evidence of any detectable technetium-99 macroaggregated albumin (Tc-99 MAA) flow to the stomach or duodenum after application of established angiographic techniques to stop such flow
- No comorbid disease or condition that would preclude safe delivery of yttrium Y 90 glass microspheres and place patient at undue risk
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy
- More than 2 weeks since prior surgery
- At least 2 weeks since prior radiosensitizing chemotherapy
- More than 6 weeks since prior carmustine (BCNU) or mitomycin C
- No other concurrent cancer therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
About this study
Official title: A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.
PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating patients with metastatic liver cancer that cannot be removed by surgery.
Read the detailed description
OBJECTIVES:
- Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients who are not candidates for surgical resection of metastatic intrahepatic carcinoma.
- Evaluate patient experience and toxicities associated with yttrium Y 90 glass microspheres treatment.
OUTLINE: This is a humanitarian device exemption use study.
Patients receive yttrium Y 90 glass microspheres (TheraSphere®) into the liver tumor through a percutaneously placed catheter into the hepatic artery. Patients may receive additional therapy 4-12 weeks after initial treatment at the discretion of the study physician.
After completion of study therapy, patients are followed at 2 weeks, 30 days, and then once a year for approximately 2 years.
- Conditions
- Liver Cancer, Metastatic Cancer
- Being tested
- Yttrium Y 90 glass microspheres
- Keywords
- liver metastases, advanced adult primary liver cancer
- 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.
Yttrium Y 90 glass microspheresRadiation
Between 0.2 to 0.5 Curies (200-500-mCi), either single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart per treating physician's discretion.
| Study group | Role | What they receive |
|---|---|---|
| All Patients | Patients with metastatic cancer of the liver who are not surgical resection candidates and who will be treated with TheraSphere per institutional standard of care. Receives: Radiation: Yttrium Y 90 glass microspheres |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startDec 2004
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Riad Salem, MD, Study chair, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532740
- Sponsor's protocol ID
- NU 1365-002
- Other IDs
- P30CA060553, NU-1365-002
- Status last verified
- Aug 2022
- First submitted
- 18 Sep 2007
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rhee TK, Lewandowski RJ, Liu DM, Mulcahy MF, Takahashi G, Hansen PD, Benson AB 3rd, Kennedy AS, Omary RA, Salem R. 90Y Radioembolization for metastatic neuroendocrine liver tumors: preliminary results from a multi-institutional experience. Ann Surg. 2008 Jun;247(6):1029-35. doi: 10.1097/SLA.0b013e3181728a45.
PubMed 18520231Sato KT, Lewandowski RJ, Mulcahy MF, Atassi B, Ryu RK, Gates VL, Nemcek AA Jr, Barakat O, Benson A 3rd, Mandal R, Talamonti M, Wong CY, Miller FH, Newman SB, Shaw JM, Thurston KG, Omary RA, Salem R. Unresectable chemorefractory liver metastases: radioembolization with 90Y microspheres--safety, efficacy, and survival. Radiology. 2008 May;247(2):507-15. doi: 10.1148/radiol.2472062029. Epub 2008 Mar 18.
PubMed 18349311
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver
- ClinicalTrials.gov ID
- NCT00532740
- Acronym / sponsor ID
- NU 1365-002
- Conditions
- Liver Cancer, Metastatic Cancer
- Keywords
- liver metastases, advanced adult primary liver cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2004
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 20 Sep 2007 (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.
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.
PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating patients with metastatic liver cancer that cannot be removed by surgery.
Detailed description
OBJECTIVES:
- Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients who are not candidates for surgical resection of metastatic intrahepatic carcinoma.
- Evaluate patient experience and toxicities associated with yttrium Y 90 glass microspheres treatment.
OUTLINE: This is a humanitarian device exemption use study.
Patients receive yttrium Y 90 glass microspheres (TheraSphere®) into the liver tumor through a percutaneously placed catheter into the hepatic artery. Patients may receive additional therapy 4-12 weeks after initial treatment at the discretion of the study physician.
After completion of study therapy, patients are followed at 2 weeks, 30 days, and then once a year for approximately 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients | – | Radiation: Yttrium Y 90 glass microspheresPatients with metastatic cancer of the liver who are not surgical resection candidates and who will be treated with TheraSphere per institutional standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic cancer of the liver who are not surgical resection candidates.
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 Y 90 glass microspheresBetween 0.2 to 0.5 Curies (200-500-mCi), either single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart per treating physician's discretion. | Radiation | All Patients |
Primary outcome
Not reported in the source record.
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 12 Aug 2022.
- Results publication: PubMed 18520231Rhee TK, Lewandowski RJ, Liu DM, Mulcahy MF, Takahashi G, Hansen PD, Benson AB 3rd, Kennedy AS, Omary RA, Salem R. 90Y Radioembolization for metastatic neuroendocrine liver tumors: preliminary results from a multi-institutional experience. Ann Surg. 2008 Jun;247(6):1029-35. doi: 10.1097/SLA.0b013e3181728a45.
- Results publication: PubMed 18349311Sato KT, Lewandowski RJ, Mulcahy MF, Atassi B, Ryu RK, Gates VL, Nemcek AA Jr, Barakat O, Benson A 3rd, Mandal R, Talamonti M, Wong CY, Miller FH, Newman SB, Shaw JM, Thurston KG, Omary RA, Salem R. Unresectable chemorefractory liver metastases: radioembolization with 90Y microspheres--safety, efficacy, and survival. Radiology. 2008 May;247(2):507-15. doi: 10.1148/radiol.2472062029. Epub 2008 Mar 18.
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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.
Riad Salem, MD study chair
Robert H. Lurie Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer and Metastatic Cancer, run by Northwestern University at 1 site 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?
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 12 Aug 2022. 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 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00532740, which also lists 2 linked publications.
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 12 Aug 2022.