Colon CancerPhase 1NCT00972036
Selective Internal Radiation Therapy (SIRT) in Patients With Unresectable Colorectal Cancer Liver Metastases Who Failed Prior Intraarterial Pump Chemotherapy
A Phase 1 study testing SIR-spheres® (Selective Internal Radiation Therapy) in people with Colon Cancer and Rectal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study is being done with a new therapy called "Selective Internal Radiation Therapy" (known as SIRT). Radiation is an effective treatment for destroying tumors. It is widely used in cancer treatment. However, radiation can harm normal tissue. SIR-Spheres are tiny plastic beads. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- SIR-spheres® (Selective Internal Radiation Therapy)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2014
- Phase
- Phase 1
- 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
- Histologic confirmation of colorectal cancer.
- Unequivocal imaging of hepatic metastases.
- Dominant Liver metastases. (Small amount extrahepatic disease allowed.)
- Unresectable liver metastases.
- Liver Metastases non-eligible for, or progressed after ablation
- Failed prior HAC.
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- ECOG performance status 0 - 1
- WBC > or = to 1.5 x 109/L
- Platelets > or = to 50 x 109/L
- Creatinine ≤ 1.5 mg/dl
- Bilirubin ≤ 1.5 mg/dl
- Age > or = to 18 years
- Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active, must agree to use an acceptable method of contraception.
- Male patients must be surgically sterile, or if sexually active, must agree to use an acceptable method of contraception.
- Life expectancy of at least 3 months without any active treatment.
- No chemotherapy regimen administration for at least 4 weeks prior to SIRT administration
Who cannot join
- Evidence of severe cirrhosis (CHILDS B and C), portal hypertension with gastroesophageal varices and liver failure as determined by clinical, radiologic or laboratory assessment.
- Previous radiotherapy delivered to the liver.
- Pregnant or breast-feeding.
- Any of the following are contraindications to the use of Yttrium-90 microspheres, and are therefore exclusion criteria:
- With a Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy that shows any disposition to the gastrointestinal tract that cannot be corrected by angiographic and embolization techniques.
- With more than 20% shunting of blood to the lungs as estimated in the Lung Scintigram performed after the intraarterial injection of Tc MAA. Radiation pneumonitis has been seen in patients receiving doses of Yttrium-90 greater than 30 Gy in a single treatment. This corresponds to the shunt over 20% presence of vascular abnormalities, bleeding diathesis, making catheterization of the hepatic artery contraindication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center 1275 York Avenue
New York, New York, 10065
About this study
Official title: Phase I Study of Selective Internal Radiation Therapy (SIRT) in Patients With Unresectable Colorectal Cancer Liver Metastases Who Failed Prior Intraarterial Pump Chemotherapy
This study is being done with a new therapy called "Selective Internal Radiation Therapy" (known as SIRT). Radiation is an effective treatment for destroying tumors. It is widely used in cancer treatment. However, radiation can harm normal tissue. SIR-Spheres are tiny plastic beads. They contain a radioactive agent called Yttrium-90. These beads can be delivered through a small tube inserted into the blood vessel that goes directly to the tumor. The radiation goes directly to the tumor. This spares healthy parts of your liver.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- SIR-spheres® (Selective Internal Radiation Therapy)
- Keywords
- COLON, LIVER, RECTUM, SIR-Spheres, 09-030
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIR-spheres® (Selective Internal Radiation Therapy)Device
SIR-spheres® will be administered at 70%, 85% and 100% of the calculated individual patient dose (approximately 1 month prior to SIR-spheres® administration).The first cohort will receive SIRSpheres® at 70% of the individually calculated patient dose, the second will receive 85% of the calculated patient dose, and the third will receive 100% of the calculated patient dose.
| Study group | Role | What they receive |
|---|---|---|
| Unresectable colon cancer patients with liver metastases | Experimental | This study will be performed to evaluate the safety of Selective Internal Radiation Therapy (SIRT) in patients with liver only colorectal cancer metastases that have received hepatic arterial infusion pump and have progressed through at least one line of chemotherapy. Receives: Device: SIR-spheres® (Selective Internal Radiation Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety, toxicity, and maximum tolerated dose of SIR-Spheres® in patients with unresectable metastatic colorectal cancer to the liver (CLM) who have received previous hepatic arterial infusion chemotherapy (HAC).
Measured: 2 years
Secondary outcomes (1)
To obtain preliminary evidence of any clinical efficacy of the SIRT therapy in these heavily pretreated patients with unresectable CLM who have received hepatic arterial infusion pump and have failed at least one line of prior chemotherapy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sirtex Medical
- Responsible party
- Sponsor
- Investigators
- Constantinos Sofocleous, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972036
- Sponsor's protocol ID
- 09-030
- Status last verified
- Dec 2014
- First submitted
- 3 Sep 2009
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Selective Internal Radiation Therapy (SIRT) in Patients With Unresectable Colorectal Cancer Liver Metastases Who Failed Prior Intraarterial Pump Chemotherapy
- ClinicalTrials.gov ID
- NCT00972036
- Acronym / sponsor ID
- 09-030
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- COLON, LIVER, RECTUM, SIR-Spheres, 09-030
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Sirtex Medical
- Study start
- Aug 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Sep 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 being done with a new therapy called "Selective Internal Radiation Therapy" (known as SIRT). Radiation is an effective treatment for destroying tumors. It is widely used in cancer treatment. However, radiation can harm normal tissue. SIR-Spheres are tiny plastic beads. They contain a radioactive agent called Yttrium-90. These beads can be delivered through a small tube inserted into the blood vessel that goes directly to the tumor. The radiation goes directly to the tumor. This spares healthy parts of your liver.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unresectable colon cancer patients with liver metastases | Experimental | Device: SIR-spheres® (Selective Internal Radiation Therapy)This study will be performed to evaluate the safety of Selective Internal Radiation Therapy (SIRT) in patients with liver only colorectal cancer metastases that have received hepatic arterial infusion pump and have progressed through at least one line of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologic confirmation of colorectal cancer.
- Unequivocal imaging of hepatic metastases.
- Dominant Liver metastases. (Small amount extrahepatic disease allowed.)
- Unresectable liver metastases.
- Liver Metastases non-eligible for, or progressed after ablation
Key exclusion criteria (6 listed)
- Evidence of severe cirrhosis (CHILDS B and C), portal hypertension with gastroesophageal varices and liver failure as determined by clinical, radiologic or laboratory assessment.
- Previous radiotherapy delivered to the liver.
- Pregnant or breast-feeding.
- Any of the following are contraindications to the use of Yttrium-90 microspheres, and are therefore exclusion criteria:
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 |
|---|---|---|
| SIR-spheres® (Selective Internal Radiation Therapy)SIR-spheres® will be administered at 70%, 85% and 100% of the calculated individual patient dose (approximately 1 month prior to SIR-spheres® administration).The first cohort will receive SIRSpheres® at 70% of the individually calculated patient dose, the second will receive 85% of the calculated patient dose, and the third will receive 100% of the calculated patient dose. | Device | Unresectable colon cancer patients with liver metastases |
Primary outcome
To determine the safety, toxicity, and maximum tolerated dose of SIR-Spheres® in patients with unresectable metastatic colorectal cancer to the liver (CLM) who have received previous hepatic arterial infusion chemotherapy (HAC).
Time frame: 2 years
1 secondary outcome
To obtain preliminary evidence of any clinical efficacy of the SIRT therapy in these heavily pretreated patients with unresectable CLM who have received hepatic arterial infusion pump and have failed at least one line of prior chemotherapy.
Time frame: 2 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 11 Dec 2014.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Constantinos Sofocleous, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIR-spheres® (Selective Internal Radiation Therapy) in people with Colon Cancer and Rectal Cancer, run by Memorial Sloan Kettering Cancer Center 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?
The sponsor lists 16 inclusion and 6 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 11 Dec 2014. 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.
What does this 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.
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?
To determine the safety, toxicity, and maximum tolerated dose of SIR-Spheres® in patients with unresectable metastatic colorectal cancer to the liver (CLM) who have received previous hepatic arterial infusion chemotherapy (HAC). (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 11 Dec 2014.