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Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver

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ClinicalTrials.gov Identifier: NCT02724540
Recruitment Status : Recruiting
First Posted : March 31, 2016
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Guerbet
Information provided by (Responsible Party):
University of Pennsylvania

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumor, Malignant Liver Metastases Device: Bland Embolization Combination Product: Transarterial chemoembolization Combination Product: Drug Eluting Beads Embolization Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver
Study Start Date : March 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1 - BE
Lobar or segmental bland embolization (BE) with microspheres (50-500 microns) to 2-5 heartbeat stasis.
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.
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.
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




Primary Outcome Measures :
  1. Abdominal MRI/Triple Phase CT [ Time Frame: 2 years ]
    Hepatic progression-free interval (H-PFS)


Secondary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 2 years ]
    Symptom-relief interval and toxicity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  • Contraindications to arteriography and selective visceral catheterization:

    1. severe allergy or intolerance to contrast media, narcotics, sedatives, or atropine.
    2. bleeding diathesis not correctable by usual forms of therapy.
    3. severe peripheral vascular disease precluding catheterization.
  • Contraindications to hepatic artery embolization:

    1. portal vein occlusion without hepatopedal collateral flow demonstrated by angiography; or portal hypertension with hepatofugal flow.
    2. hepatic encephalopathy.

Information from the National Library of Medicine

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


Contacts
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Contact: Michael C Soulen, MD, FSIR 855-216-0098 michael.soulen@uphs.upenn.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Nicholas Feldman, MD         
Principal Investigator: Nicholas Feldman, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Nishita Kothary, MD         
Principal Investigator: Nishita Kothary, MD         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Ghassan El-Haddad, MD         
Principal Investigator: Ghassan El-Haddad, MD         
United States, Louisiana
Ochsner Medical Center Recruiting
Baton Rouge, Louisiana, United States, 70816
Contact: Juan Gimenez, MD         
Principal Investigator: Juan Gimenez, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Kenneth Kolbeck, MD, PhD         
Principal Investigator: Kenneth Kolbeck, MD, PhD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michael C Soulen, MD, FSIR    855-216-0098    michael.soulen@uphs.upenn.edu   
Principal Investigator: Michael C Soulen, MD, FSIR         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Rony Avritscher, MD         
Principal Investigator: Rony Avritscher, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Sarah B White, MD, MS         
Principal Investigator: Sarah B White, MD, MS         
Argentina
Hospital Italiano de Buenos Aires Recruiting
Buenos Aires, Argentina, C1191 ABH
Contact: Ricardo Monaco-Garcia, MD         
Principal Investigator: Ricardo Monaco-Garcia, MD         
Sponsors and Collaborators
University of Pennsylvania
Guerbet
Investigators
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Principal Investigator: Michael C Soulen, MD, FSIR University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02724540     History of Changes
Other Study ID Numbers: UPCC 01215
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplastic Processes
Pathologic Processes
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action