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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

Tracking Information
First Submitted Date  ICMJE March 28, 2016
First Posted Date  ICMJE March 31, 2016
Last Update Posted Date March 19, 2019
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
Abdominal MRI/Triple Phase CT [ Time Frame: 2 years ]
Hepatic progression-free interval (H-PFS)
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2016)
Number of Adverse Events [ Time Frame: 2 years ]
Change History Complete list of historical versions of study NCT02724540 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
Number of Adverse Events [ Time Frame: 2 years ]
Symptom-relief interval and toxicity
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver
Official Title  ICMJE Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Neuroendocrine Tumor, Malignant
  • Liver Metastases
Intervention  ICMJE
  • Device: Bland Embolization
    Lobar or segmental bland embolization with microspheres (50-500 microns) to 2-5 heartbeat stasis
    Other Name: BE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Arm 1 - BE
    Lobar or segmental bland embolization (BE) with microspheres (50-500 microns) to 2-5 heartbeat stasis.
    Intervention: Device: Bland Embolization
  • 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.
    Intervention: Combination Product: Transarterial chemoembolization
  • 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.
    Intervention: Combination Product: Drug Eluting Beads Embolization
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 15, 2019)
180
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2016)
12
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael C Soulen, MD, FSIR 855-216-0098 michael.soulen@uphs.upenn.edu
Listed Location Countries  ICMJE Argentina,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02724540
Other Study ID Numbers  ICMJE UPCC 01215
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Guerbet
Investigators  ICMJE
Principal Investigator: Michael C Soulen, MD, FSIR University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP