Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/23/2018
Start Date:March 2016
End Date:March 2021
Contact:Michael C Soulen, MD, FSIR
Email:michael.soulen@uphs.upenn.edu
Phone:855-216-0098

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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.


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.
We found this trial at
9
sites
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Sarah B White, MD, MS
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Michael C Soulen, MD, FSIR
Phone: 855-216-0098
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Kenneth Kolbeck, MD, PhD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Baton Rouge, Louisiana 70816
Principal Investigator: Juan Gimenez, MD
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Baton Rouge, LA
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Buenos Aires,
Principal Investigator: Ricardo Monaco-Garcia, MD
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Buenos Aires,
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Houston, Texas 77030
Principal Investigator: Rony Avritscher, MD
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Houston, TX
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San Francisco, California 94143
Principal Investigator: Nicholas Feldman, MD
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San Francisco, CA
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Nishita Kothary, MD
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stanford, CA
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Tampa, Florida 33612
Principal Investigator: Ghassan El-Haddad, MD
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Tampa, FL
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