Colorectal NeoplasmsNCT01098422
A Study of Yttrium-90 Radioactive Resin Microspheres to Treat Colorectal Adenocarcinoma Metastatic to the Liver
A study testing Yttrium-90 Radioactive Resin Microspheres in people with Colorectal Neoplasms and Liver Neoplasms, run by Tony Reid, M.D., Ph.D. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness of radioactive microsphere infusion as a treatment for liver metastases from colon or rectal cancer. The investigators hypothesis is that the administration of microspheres between first and second line chemotherapy will increase progression-free survival… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Liver Neoplasms
- What is being tested?
- Yttrium-90 Radioactive Resin Microspheres
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to Feb 2015
- Phase
- Interventional
- 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
- Histologically confirmed colorectal carcinoma. Liver metastasis will be confirmed by either PET scan or biopsy.
- Ability to understand and willingness to sign written informed consent
- Minimum of 18 years of age
- Liver dominant metastases measurable by CT or MRI and therefore amenable to serial assessment using RECIST criteria
- Progressive disease of metastatic colorectal carcinoma on first line combination chemotherapy with a 5-fluorouracil/leucovorin with oxaliplatin (FOLFOX) based regimen (Folinic Acid, Oxaliplatin and Fluorouracil)or failure of first line chemotherapy due to toxicity
- Candidate for second line chemotherapy with a fluorouracil, leucovorin, and irinotecan (FOLFIRI) regimen. Per standard of care, second line chemotherapy will not include Bevacizumab.
Show all 11Show fewer
- Karnofsky Performance Score (KPS) of 70% or greater
- Life expectancy of greater than or equal to four months by investigator estimation
- Females with negative urine or serum pregnancy test
- Effective double barrier contraception for a minimum of two months following the final infusion of microspheres
- Patients who are not candidates for transarterial chemoembolization (TACE), thermal ablation or surgical resection
Who cannot join
- Dominant extra-hepatic disease including cerebral metastases or other extra-hepatic metastases that are symptomatic
- Large volume ascites assessed by cross sectional CT imaging
- Any chemotherapy < 4 weeks prior to the first microsphere treatment
- Anticipated to need Avastin chemotherapy within eight weeks of day M1
- Absolute neutrophil count (ANC) < 1.5 x 109/L
- Platelets (PLT) < 60,000/mm3
Show all 29Show fewer
- Hemoglobin (Hgb) < 9.0 gm/dL
- Prothrombin time (PT) or Partial Prothrombin time (PTT) > upper limit of normal (ULN)
- Serum Creatinine > 2.0 mg/dL
- Forced expiratory volume (FEV1) < 1L by baseline pulmonary function tests (ordered if investigator judges it to be clinically indicated)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limits of normal (ULN) or total bilirubin > 2.0 mg/dL
- History of incompetent sphincter of oddi (e.g.: sphincterotomy, biliary-enteric anastamosis, or percutaneous biliary drain)
- Severe hypoalbuminemia (albumin < 2.0 g/dL)
- Alkaline phosphatase > 2.5 times ULN
- Greater than 20% lung shunting (determined by the MAA - Tc 99 nuclear medicine lung shunt scan)
- Pre assessment angiogram and MAA scan demonstrating any uncorrectable activity in the stomach, bowel or pancreas
- Major surgery < 4 weeks prior to the first microsphere treatment
- Female who is pregnant or nursing
- Men and women of childbearing potential wishing to conceive < 2 months following the completion of the microsphere portion of the study.
- Any investigational agent administered < 4 weeks prior to microsphere treatment
- A known history of hepatitis B or hepatitis C
- Known hypersensitivity to any component of microsphere infusion
- History of, or current coagulation or bleeding disorder
- History of significant hepatic cirrhosis, fibrosis or hemochromatosis
- History of malignancy, other than colorectal cancer, within five years of the start of study participation, except in situ cervical or skin cancer
- Active severe infection or any other concurrent disease or medical conditions that are likely to interfere with the study as judged by the investigator
- Prior treatment with radioactive microspheres or external beam radiation therapy to the liver
- Prophylactic anticoagulation and nonsteroidal antiplatelet drugs are only a contraindication, if the PT/PTT are above the ULN. Plavix (clopidogrel) will need to be stopped 5 days prior to the hepatic-angiogram and the microsphere procedures, then started the next day.
- History of right to left, bi-directional or transient right to left cardiac shunts, worsening or clinically unstable congestive heart failure, acute myocardial infarction or acute coronary syndromes serious ventricular arrhythmias or high risk for arrhythmias due to prolongation of the QT interval, respiratory failure as manifested by signs or symptoms of carbon dioxide retention or hypoxemia or severe emphysema, pulmonary emboli or other conditions that causes pulmonary hypertension due to compromised pulmonary arterial vasculature
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093
UCSD Medical Center
San Diego, California, 92103
About this study
Official title: A Phase II Study of Yttrium-90 Radioactive Resin Microspheres in the Treatment of Colorectal Adenocarcinoma Metastatic to the Liver After Failure of First-Line Combination Chemotherapy
The purpose of this study is to determine the effectiveness of radioactive microsphere infusion as a treatment for liver metastases from colon or rectal cancer. The investigators hypothesis is that the administration of microspheres between first and second line chemotherapy will increase progression-free survival time by about 2.5 months and may also improve tumor response rates to subsequent second line chemotherapy.
Read the detailed description
This is a phase II, single-arm study of Yttrium-90 (Y-90) radioactive resin microspheres in the treatment of colorectal adenocarcinoma metastatic to the liver in patients who have had progressive disease through first line combination chemotherapy or have otherwise failed first line chemotherapy due to toxicity. Expected enrollment at University of California, San Diego (UCSD) is approximately 34 subjects.
The dose of Yttrium-90 radioactive resin microspheres is calculated based on body surface area (to estimate normal liver volume), percentage of total liver represented by the targeted lobe, and percentage of the lobe that is occupied by tumor, corrected for percentage lung shunt. The prescribed dose, calculated by the nuclear medicine physician, will be delivered by the interventional radiologist using the standard delivery system with frequent fluoroscopic monitoring to assure ante grade blood flow immediately after treatment. Additional current standard practice includes obtaining a nuclear medicine scan of the patient immediately after each therapeutic Yttrium-90 microspheres administration to prove delivery of the agent to the targeted portion of the liver and absence of either extra-hepatic Yttrium-90 delivery or free Yttrium-90.
Blood samples will be obtained one week after the first treatment with microspheres. If the patient has bi-lobar disease and the results of lab tests meet protocol specified criteria, the dose will be repeated in the initially-untreated lobe. If the lab tests do not meet protocol specified criteria (i.e. study inclusion/exclusion criteria), the treatment will be deferred for fourteen days and labs repeated. If they are then within parameters, the patient will receive the second dose. If they are not within parameters, the patient will proceed to chemotherapy.
Patients will remain off chemotherapy after their final microspheres treatment for a minimum of three weeks. Second line treatment options include FDA approved anti-neoplastic agents used in colorectal cancer metastatic to the liver with the exception of bevacizumab and capecitabine, which has been less rigorously studied with relation to Yttrium-90 radioactive microspheres and therefore will not be used. When patients are found to have progressive disease while receiving second line chemotherapy, they will then undergo a comprehensive clinical, laboratory, and imaging assessment and enter the follow-up phase in which they are assessed every five to seven months until death or withdrawal of consent.
A contrast enhanced ultrasound (CEUS) will be performed pre microsphere treatment (within 14 days), post microsphere treatment (2 weeks, 4 weeks, 8 weeks and 12 weeks post the microsphere treatment). If patients require two treatments with microspheres, they will be evaluated 2, 4, 8 and 12 weeks post the second treatment.
- Conditions
- Colorectal Neoplasms, Liver Neoplasms
- Being tested
- Yttrium-90 Radioactive Resin Microspheres
- Keywords
- liver, colorectal, metastasis, carcinoma, Yttrium-90, microspheres
- Medical subject headings
- Colorectal Neoplasms, Liver Neoplasms, Neoplasm Metastasis, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yttrium-90 Radioactive Resin MicrospheresDevice
An injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity.
| Study group | Role | What they receive |
|---|---|---|
| Yttrium-90 Radioactive Resin Microspheres | Experimental | Yttrium-90 Radioactive Resin Microspheres Receives: Device: Yttrium-90 Radioactive Resin Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria using Computerized Tomography (CT) assessment of tumor(s)
Measured: 2 years
Secondary outcomes (4)
Percentage of Participants Achieving Overall Survival at 6 Months
Overall survival assessed at 6 months since diagnosis of progression on first-line therapy
Measured: 6 Months
Number of Participants With Responses as Determined by RECIST Criteria Using CT or Magnetic Resonance Imaging (MRI) Assessment
Tumor response rate as determined by RECIST criteria using CT or Magnetic Resonance Imaging (MRI) assessment of tumor size every 3 months
Measured: 2 years
Adverse Events
Number of adverse events by grade
Measured: 1 years
60 Day All-cause Mortality Rate
Number of Participants with 60 Day All-cause Mortality
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Halted due to slow enrollment
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 NeoplasmsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tony Reid, M.D., Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Sirtex Medical
- Responsible party
- Sponsor-investigator, Tony Reid, M.D., Ph.D., University of California, San Diego
- Investigators
- Tony Reid, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098422
- Sponsor's protocol ID
- 071960
- Status last verified
- Aug 2021
- First submitted
- 1 Apr 2010
- Last updated
- 24 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Yttrium-90 Radioactive Resin Microspheres in the Treatment of Colorectal Adenocarcinoma Metastatic to the Liver After Failure of First-Line Combination Chemotherapy
- ClinicalTrials.gov ID
- NCT01098422
- Acronym / sponsor ID
- 071960
- Conditions
- Colorectal Neoplasms, Liver Neoplasms
- Keywords
- liver, colorectal, metastasis, carcinoma, Yttrium-90, microspheres
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted due to slow enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tony Reid, M.D., Ph.D.University, hospital or other
- Collaborators
- Sirtex Medical
- Study start
- Jan 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Posted 24 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of radioactive microsphere infusion as a treatment for liver metastases from colon or rectal cancer. The investigators hypothesis is that the administration of microspheres between first and second line chemotherapy will increase progression-free survival time by about 2.5 months and may also improve tumor response rates to subsequent second line chemotherapy.
Detailed description
This is a phase II, single-arm study of Yttrium-90 (Y-90) radioactive resin microspheres in the treatment of colorectal adenocarcinoma metastatic to the liver in patients who have had progressive disease through first line combination chemotherapy or have otherwise failed first line chemotherapy due to toxicity. Expected enrollment at University of California, San Diego (UCSD) is approximately 34 subjects.
The dose of Yttrium-90 radioactive resin microspheres is calculated based on body surface area (to estimate normal liver volume), percentage of total liver represented by the targeted lobe, and percentage of the lobe that is occupied by tumor, corrected for percentage lung shunt. The prescribed dose, calculated by the nuclear medicine physician, will be delivered by the interventional radiologist using the standard delivery system with frequent fluoroscopic monitoring to assure ante grade blood flow immediately after treatment. Additional current standard practice includes obtaining a nuclear medicine scan of the patient immediately after each therapeutic Yttrium-90 microspheres administration to prove delivery of the agent to the targeted portion of the liver and absence of either extra-hepatic Yttrium-90 delivery or free Yttrium-90.
Blood samples will be obtained one week after the first treatment with microspheres. If the patient has bi-lobar disease and the results of lab tests meet protocol specified criteria, the dose will be repeated in the initially-untreated lobe. If the lab tests do not meet protocol specified criteria (i.e. study inclusion/exclusion criteria), the treatment will be deferred for fourteen days and labs repeated. If they are then within parameters, the patient will receive the second dose. If they are not within parameters, the patient will proceed to chemotherapy.
Patients will remain off chemotherapy after their final microspheres treatment for a minimum of three weeks. Second line treatment options include FDA approved anti-neoplastic agents used in colorectal cancer metastatic to the liver with the exception of bevacizumab and capecitabine, which has been less rigorously studied with relation to Yttrium-90 radioactive microspheres and therefore will not be used. When patients are found to have progressive disease while receiving second line chemotherapy, they will then undergo a comprehensive clinical, laboratory, and imaging assessment and enter the follow-up phase in which they are assessed every five to seven months until death or withdrawal of consent.
A contrast enhanced ultrasound (CEUS) will be performed pre microsphere treatment (within 14 days), post microsphere treatment (2 weeks, 4 weeks, 8 weeks and 12 weeks post the microsphere treatment). If patients require two treatments with microspheres, they will be evaluated 2, 4, 8 and 12 weeks post the second treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yttrium-90 Radioactive Resin Microspheres | Experimental | Device: Yttrium-90 Radioactive Resin MicrospheresYttrium-90 Radioactive Resin Microspheres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed colorectal carcinoma. Liver metastasis will be confirmed by either PET scan or biopsy.
- Ability to understand and willingness to sign written informed consent
- Minimum of 18 years of age
- Liver dominant metastases measurable by CT or MRI and therefore amenable to serial assessment using RECIST criteria
- Progressive disease of metastatic colorectal carcinoma on first line combination chemotherapy with a 5-fluorouracil/leucovorin with oxaliplatin (FOLFOX) based regimen (Folinic Acid, Oxaliplatin and Fluorouracil)or failure of first line chemotherapy due to toxicity
Key exclusion criteria (29 listed)
- Dominant extra-hepatic disease including cerebral metastases or other extra-hepatic metastases that are symptomatic
- Large volume ascites assessed by cross sectional CT imaging
- Any chemotherapy < 4 weeks prior to the first microsphere treatment
- Anticipated to need Avastin chemotherapy within eight weeks of day M1
- Absolute neutrophil count (ANC) < 1.5 x 109/L
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 Radioactive Resin MicrospheresAn injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity. | Device | Yttrium-90 Radioactive Resin Microspheres |
Primary outcome
PFS
Time frame: 2 years
Progression-free survival assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria using Computerized Tomography (CT) assessment of tumor(s)
4 secondary outcomes
Percentage of Participants Achieving Overall Survival at 6 Months
Time frame: 6 Months
Number of Participants With Responses as Determined by RECIST Criteria Using CT or Magnetic Resonance Imaging (MRI) Assessment
Time frame: 2 years
Adverse Events
Time frame: 1 years
60 Day All-cause Mortality Rate
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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.
Tony Reid, MD, PhD principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yttrium-90 Radioactive Resin Microspheres in people with Colorectal Neoplasms and Liver Neoplasms, run by Tony Reid, M.D., Ph.D. at 2 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 11 inclusion and 29 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: stopped early, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2021). 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?
PFS (time frame: 2 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 24 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.