Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver

Liver Metastases Clinical Trial

Official title:

Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02724540
• Other study ID #: UPCC 01215
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 162
• Est. completion date: September 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Metastases
• Neoplasm Metastasis
• Neuroendocrine Tumor, Malignant
• Neuroendocrine Tumors

Intervention

Device:
• Bland Embolization
Lobar or segmental bland embolization with microspheres (50-500 microns) to 2-5 heartbeat stasis

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.
• 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.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Italy	Ospedale San Raffaele	Milan
United States	MD Anderson Cancer Center	Houston	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	University of California San Francisco	San Francisco	California
United States	Stanford University	Stanford	California
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	Guerbet

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal MRI/Triple Phase CT	Hepatic progression-free interval (H-PFS)	2 years
Secondary	Number of Adverse Events	Symptom-relief interval and toxicity	2 years