Neuroendocrine Tumor, MalignantPhase 2NCT02724540
Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver
A Phase 2 study testing Bland Embolization, Transarterial chemoembolization and Drug Eluting Beads Embolization in people with Neuroendocrine Tumor, Malignant and Liver Metastases, run by Abramson Cancer Center at Penn Medicine at 13 sites in 4 countries.
Trial summary
The primary aim of this trial is to estimate the duration of hepatic progression-free survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial Lipiodol chemoembolization (TACE), and embolization by drug-eluting beads (DEB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumor, Malignant, Liver Metastases
- What is being tested?
- Bland Embolization, Transarterial chemoembolization and Drug Eluting Beads Embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 13 sitesin 4 countries
- Study dates
- Mar 2016to 8 Nov 2024
- Phase
- Phase 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
- Participants 18 years and older;
- Biopsy-proven neuroendocrine tumor.
- Measurable metastasis to liver with at least one dimension ≥ 1.0 cm.
- Tumor burden dominant in the liver AND liver tumor burden less than or equal to 70% of the total liver volume by visual estimate.
- Not a candidate for surgical resection based on unresectability, anatomy, anesthesia risk, patient preference.
- Symptoms uncontrolled by somatostatin analogues OR morphologically progressive tumor by RECIST 1.1 criteria in the liver OR baseline tumor burden >25% of the liver volume.
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- There must be no plans for the patient to receive other concomitant therapy while on this protocol treatment (other than somatostatin analogs or bone-strengthening agents).
- Performance status 0-2 on Zubrod/ECOG Performance Scale;
- Serum creatinine < 2.0 mg/dL;
- Serum Bilirubin ≤ 2.0 mg/dL
- Serum albumin ≥ 3.0 g/dL
- Platelet count > 50 thousands/uL (corrected if needed)
- INR ≤ 1.5 (corrected if needed)
- All patients must be informed of the investigational nature of this study and must sign a study specific informed consent in accordance with institutional and federal guidelines prior to study entry.
Who cannot join
- Pregnant or lactating women may not participate due to the embryotoxic effects of protocol treatment. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Prior hepatic arterial therapy or hepatic radiation therapy. Prior surgical resection or ablation of liver metastases is acceptable. Patients must be at least one month beyond prior chemotherapy, PRRT, ablation or surgery, and have recovered from all therapy-associated toxicities.
- Active infection (Symptomatic bacterial and fungal infection - newly diagnosed and/or requiring treatment);
- Choledochoenteric anastomosis; transpapillary biliary stent, or sphincterotomy of duodenal papilla
- Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication).
- Contraindications to arteriography and selective visceral catheterization:
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- severe allergy or intolerance to contrast media, narcotics, sedatives, or atropine.
- bleeding diathesis not correctable by usual forms of therapy.
- severe peripheral vascular disease precluding catheterization.
- Contraindications to hepatic artery embolization:
- portal vein occlusion without hepatopedal collateral flow demonstrated by angiography; or portal hypertension with hepatofugal flow.
- hepatic encephalopathy.
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
United States10 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Mount Sinai School of Medicine
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University
Portland, Oregon, 97239
University of California San Francisco
San Francisco, California, 94143
Stanford University
Standford, California, 94305
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
The primary aim of this trial is to estimate the duration of hepatic progression-free survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial Lipiodol chemoembolization (TACE), and embolization by drug-eluting beads (DEB). The primary hypothesis is that chemoembolization will be nearly twice as durable as bland embolization; thatis, the hazard ratio for HPFS will be 1.76 or better.
- Conditions
- Neuroendocrine Tumor, Malignant, Liver Metastases
- Being tested
- Bland Embolization, Transarterial chemoembolization, Drug Eluting Beads Embolization
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bland EmbolizationDevice
Also called BE
Lobar or segmental bland embolization with microspheres (50-500 microns) to 2-5 heartbeat stasis
Transarterial chemoembolizationCombination product
Also called TACE
Lobar or segmental lipiodol transarterial chemoembolization. Doxorubicin 50 mg dissolved in 10 mL dilute contrast and emulsified with 10-20 cc iodized oil, followed by 50-500 μm microspheres.
Drug Eluting Beads EmbolizationCombination product
Also called DEB
CLOSED - Lobar or segmental hepatic chemoembolization with DEBDOX (100-300 or 300-500 micron beads loaded with doxorubicin per manufacturer IFU.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - BE | Experimental | Lobar or segmental bland embolization (BE) with microspheres (50-500 microns) to 2-5 heartbeat stasis. Receives: Device: Bland Embolization |
| Arm 2 - TACE | Experimental | Lobar or segmental lipiodol conventional transarterial chemoembolization (TACE). Doxorubicin 50 mg dissolved in 10 mL dilute contrast and emulsified with 10-20 cc iodized oil, followed by 50-500 μm microspheres. Receives: Combination Product: Transarterial chemoembolization |
| Arm 3 - DEB - CLOSED | Experimental | Lobar or segmental hepatic chemoembolization with DEBDOX (100-300 or 300-500 micron beads loaded with doxorubicin per manufacturer IFU monthly until entire tumor burden is treated. Receives: Combination Product: Drug Eluting Beads Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal MRI/Triple Phase CT
Hepatic progression-free interval (H-PFS)
Measured: 2 years
Secondary outcomes (1)
Number of Adverse Events
Symptom-relief interval and toxicity
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 posted31 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion30 Apr 2024
- Study completion8 Nov 2024
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 Neuroendocrine Tumor, MalignantStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet
- Responsible party
- Sponsor
- Investigators
- Michael C Soulen, MD, FSIR, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724540
- Sponsor's protocol ID
- UPCC 01215
- Status last verified
- Jan 2025
- First submitted
- 28 Mar 2016
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chen JX, Wileyto EP, Soulen MC. Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver (RETNET): study protocol for a randomized controlled trial. Trials. 2018 Jul 17;19(1):390. doi: 10.1186/s13063-018-2782-5.
PubMed 30016989
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver
- ClinicalTrials.gov ID
- NCT02724540
- Acronym / sponsor ID
- UPCC 01215
- Conditions
- Neuroendocrine Tumor, Malignant, Liver Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Guerbet
- Study start
- Mar 2016 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 31 Mar 2016 (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.
The primary aim of this trial is to estimate the duration of hepatic progression-free survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial Lipiodol chemoembolization (TACE), and embolization by drug-eluting beads (DEB). The primary hypothesis is that chemoembolization will be nearly twice as durable as bland embolization; thatis, the hazard ratio for HPFS will be 1.76 or better.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - BE | Experimental | Device: Bland EmbolizationLobar or segmental bland embolization (BE) with microspheres (50-500 microns) to 2-5 heartbeat stasis. |
| Arm 2 - TACE | Experimental | Combination Product: Transarterial chemoembolizationLobar or segmental lipiodol conventional transarterial chemoembolization (TACE). Doxorubicin 50 mg dissolved in 10 mL dilute contrast and emulsified with 10-20 cc iodized oil, followed by 50-500 μm microspheres. |
| Arm 3 - DEB - CLOSED | Experimental | Combination Product: Drug Eluting Beads EmbolizationLobar or segmental hepatic chemoembolization with DEBDOX (100-300 or 300-500 micron beads loaded with doxorubicin per manufacturer IFU monthly until entire tumor burden is treated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants 18 years and older;
- Biopsy-proven neuroendocrine tumor.
- Measurable metastasis to liver with at least one dimension ≥ 1.0 cm.
- Tumor burden dominant in the liver AND liver tumor burden less than or equal to 70% of the total liver volume by visual estimate.
- Not a candidate for surgical resection based on unresectability, anatomy, anesthesia risk, patient preference.
Key exclusion criteria (12 listed)
- Pregnant or lactating women may not participate due to the embryotoxic effects of protocol treatment. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Prior hepatic arterial therapy or hepatic radiation therapy. Prior surgical resection or ablation of liver metastases is acceptable. Patients must be at least one month beyond prior chemotherapy, PRRT, ablation or surgery, and have recovered from all therapy-associated toxicities.
- Active infection (Symptomatic bacterial and fungal infection - newly diagnosed and/or requiring treatment);
- Choledochoenteric anastomosis; transpapillary biliary stent, or sphincterotomy of duodenal papilla
- Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication).
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 |
|---|---|---|
| Bland EmbolizationAlso: BELobar or segmental bland embolization with microspheres (50-500 microns) to 2-5 heartbeat stasis | Device | Arm 1 - BE |
| Transarterial chemoembolizationAlso: TACELobar or segmental lipiodol transarterial chemoembolization. Doxorubicin 50 mg dissolved in 10 mL dilute contrast and emulsified with 10-20 cc iodized oil, followed by 50-500 μm microspheres. | Combination product | Arm 2 - TACE |
| Drug Eluting Beads EmbolizationAlso: DEBCLOSED - Lobar or segmental hepatic chemoembolization with DEBDOX (100-300 or 300-500 micron beads loaded with doxorubicin per manufacturer IFU. | Combination product | Arm 3 - DEB - CLOSED |
Primary outcome
Abdominal MRI/Triple Phase CT
Time frame: 2 years
Hepatic progression-free interval (H-PFS)
1 secondary outcome
Number of Adverse Events
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 6 Jan 2025.
- Derived from this study: PubMed 30016989Chen JX, Wileyto EP, Soulen MC. Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver (RETNET): study protocol for a randomized controlled trial. Trials. 2018 Jul 17;19(1):390. doi: 10.1186/s13063-018-2782-5.
- Individual participant dataSharing planned: No
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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.
Michael C Soulen, MD, FSIR principal investigator
University of Pennsylvania
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bland Embolization, Transarterial chemoembolization and Drug Eluting Beads Embolization in people with Neuroendocrine Tumor, Malignant and Liver Metastases, run by Abramson Cancer Center at Penn Medicine at 13 sites in 4 countries.
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 12 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 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Argentina, Canada, Italy. 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?
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?
Abdominal MRI/Triple Phase CT (time frame: 2 years). 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 NCT02724540, 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 6 Jan 2025.