Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver
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ClinicalTrials.gov Identifier: NCT02724540 |
Recruitment Status :
Active, not recruiting
First Posted : March 31, 2016
Last Update Posted : May 4, 2022
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Condition or disease | Intervention/treatment | Phase |
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Neuroendocrine Tumor, Malignant Liver Metastases | Device: Bland Embolization Combination Product: Transarterial chemoembolization Combination Product: Drug Eluting Beads Embolization | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 162 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver |
Study Start Date : | March 2016 |
Estimated Primary Completion Date : | March 2023 |
Estimated Study Completion Date : | March 2024 |

Arm | Intervention/treatment |
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Experimental: Arm 1 - BE
Lobar or segmental bland embolization (BE) with microspheres (50-500 microns) to 2-5 heartbeat stasis.
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Device: Bland Embolization
Lobar or segmental bland embolization with microspheres (50-500 microns) to 2-5 heartbeat stasis
Other Name: BE |
Experimental: Arm 2 - TACE
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.
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Combination Product: Transarterial chemoembolization
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.
Other Name: TACE |
Experimental: Arm 3 - DEB - CLOSED
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.
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Combination Product: Drug Eluting Beads Embolization
CLOSED - Lobar or segmental hepatic chemoembolization with DEBDOX (100-300 or 300-500 micron beads loaded with doxorubicin per manufacturer IFU.
Other Name: DEB |
- Abdominal MRI/Triple Phase CT [ Time Frame: 2 years ]Hepatic progression-free interval (H-PFS)
- Number of Adverse Events [ Time Frame: 2 years ]Symptom-relief interval and toxicity

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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).
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Contraindications to arteriography and selective visceral catheterization:
- 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.
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Contraindications to hepatic artery embolization:
- portal vein occlusion without hepatopedal collateral flow demonstrated by angiography; or portal hypertension with hepatofugal flow.
- hepatic encephalopathy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724540
United States, California | |
University of California San Francisco | |
San Francisco, California, United States, 94143 | |
Stanford University | |
Stanford, California, United States, 94305 | |
United States, Florida | |
Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 | |
Argentina | |
Hospital Italiano de Buenos Aires | |
Buenos Aires, Argentina, C1191 ABH | |
Canada, Ontario | |
Sunnybrook Health Sciences Centre | |
Toronto, Ontario, Canada, M4N3M5 | |
Italy | |
Ospedale San Raffaele | |
Milan, Italy, 20132 |
Principal Investigator: | Michael C Soulen, MD, FSIR | University of Pennsylvania |
Responsible Party: | Abramson Cancer Center of the University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT02724540 |
Other Study ID Numbers: |
UPCC 01215 |
First Posted: | March 31, 2016 Key Record Dates |
Last Update Posted: | May 4, 2022 |
Last Verified: | May 2022 |
Neoplasm Metastasis Neuroendocrine Tumors Neoplastic Processes Neoplasms Pathologic Processes |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue |