Clinical trial NCT02724540: Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver
Official title: Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroendocrine Tumor, Malignant
Liver Metastases
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Guerbet
First posted: 2016-03-31
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Abdominal MRI/Triple Phase CT
timeFrame: 2 years
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: 2 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Standford
country: United States
facility: Stanford University
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Milan
country: Italy
facility: Ospedale San Raffaele
Study officials:
affiliation: University of Pennsylvania
name: Michael C Soulen, MD, FSIR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.