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Gastrointestinal Diseases

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Pharmaceutical Solutions

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Endoscopic ultrasound-guided radiofrequency ablation will be performed using the "EUSRA" system (Taewoong, Seoul, Korea). The system consists of a 19-gauge needle electrode (140-cm long), a radiofrequency current generator (VIVA RF generator; Taewoong), and an inner cooling system that circulates chilled saline solution during the radiofrequency ablation procedure. The inner metal part is insulated over its entire length, with the exception of the terminal 5 to 20mm for energy delivery. The needle electrode is attached to the radiofrequency current generator and to a cooling pump. The generator, in addition to providing radiofrequency current, allows the control of physical power and impedance parameters.

Surgical resection will be performed in an inpatient setting. The type and extension of surgical resection, as well as need for lymphadenectomy, will be decided by the treating surgeons according to the tumor position, distance from the main pancreatic duct, and local expertise.

Radiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma

Endoscopic ultrasound-guided radio frequency ablation

Surgical resection of pancreatic insulinoma

Surgery

Stefano Francesco Crinò, MD

The goal of this muticentre randomized controlled trial is to compare endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) with surgery for treatment of pancreatic insulinoma. The main questions it aims to answer are: 1) What is the safest treatment? 2) Is efficacy comparable? Patients will be randomized to undergo EUS-RFA or surgical resection. Researchers will compare the rate of adverse events and the clinical efficacy after the two treatments to see if EUS-RFA result safer and effective compare with surgery.

EUS-RFA Versus Surgery for Pancreatic Insulinoma (ERASIN-RCT)

Endoscopic Ultrasound-guided RAdiofrequency Ablation Versus Surgical Resection for the Treatment of Pancreatic INsulinoma: a Multicenter Randomized Controlled Trial

Rate of overall and severe adverse events will be recorded

Rate of patients experiencing symptoms disappearance

Assessment of quality of life using a questionnaire

Rate of endocrine or exocrine pancreatic insufficiency

Azienda Ospedaliera Universitaria Integrata Verona

Doctor

Symptoms and General Pathology

Infections

Diseases and Abnormalities at or Before Birth

Carcinoma

Syndrome

Recurrence

Thyroid Diseases

Neuroendocrine Tumors

Pheochromocytoma

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Carcinoid Tumor

Carcinoma, Medullary

Carcinoma, Merkel Cell

Multiple Endocrine Neoplasia

Multiple Endocrine Neoplasia Type 1

Gastrinoma

Multiple Endocrine Neoplasia Type 2a

Multiple Endocrine Neoplasia Type 2b

Glucagonoma

Vipoma

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Zollinger-Ellison Syndrome

Thyroid Neoplasms

Carcinoma, Neuroendocrine

Disease Attributes

Neuroectodermal Tumors

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Functioning Pancreatic Endocrine Tumor

VIPoma

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Paragangliomas 1

Antineoplastic Agents

Capecitabine

Temozolomide

Veliparib

Antimetabolites

Antineoplastic Agents, Alkylating

Alkylating Agents

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Capecitabine PO BID on days 1-14, temozolomide PO BID on days 10-14 and veliparib PO BID on days 10-14.

Pharmacological Study

Laboratory Biomarker Analysis

Jordan Berlin, M.D.

This phase I trial studies the side effects and best dose of veliparib when given together with capecitabine and temozolomide in treating patients with neuroendocrine tumor that has spread to other places in the body and usually cannot be cured or controlled with treatment, has returned after a period of improvement, and cannot be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of veliparib (ABT-888) in combination with capecitabine and temozolomide in patients with advanced well-differentiated neuroendocrine tumors.

SECONDARY OBJECTIVES:

2. To determine the safety profile of the combination of capecitabine, temozolomide and veliparib in patients with advanced well-differentiated neuroendocrine tumors (NET).

3. To evaluate the antitumor activity of the combination of capecitabine, temozolomide and veliparib in advanced well-differentiated NET patients

4. To determine progression-free survival (PFS) of the combination of capecitabine, temozolomide, and veliparib in advanced well-differentiated NET patients IV. To evaluate the association between pharmacodynamic biomarkers and response in patients with advanced well-differentiated NET patients.

OUTLINE: This is a dose-escalation study of veliparib.

Patients receive capecitabine orally (PO) twice daily (BID) on days 1-14, temozolomide PO BID on days 10-14 and veliparib PO BID on days 10-14. Courses repeat every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor

A Phase 1 Study of Veliparib (ABT-888) in Combination With Capecitabine and Temozolomide in Advanced Well-Differentiated Neuroendocrine Tumors

National Cancer Institute (NCI)

Vanderbilt-Ingram Cancer Center

Professor of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EUS-RFA Versus Surgery for Pancreatic Insulinoma (ERASIN-RCT)	NCT05735912	Pancreatic Insu...	Endoscopic ultr... Surgery	18 Years -	Azienda Ospedaliera Universitaria Integrata Verona
Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor	NCT02831179	Functional Panc... Malignant Somat... Merkel Cell Car... Metastatic Adre... Metastatic Carc... Multiple Endocr... Multiple Endocr... Multiple Endocr... Neuroendocrine ... Non-Functional ... Pancreatic Gluc... Pancreatic Insu... Recurrent Adren... Recurrent Adren... Recurrent Merke... Somatostatin-Pr... Stage III Adren... Stage III Thyro... Stage IIIA Merk... Stage IIIB Merk... Stage IV Adrena... Stage IV Merkel... Stage IVA Thyro... Stage IVB Thyro... Stage IVC Thyro... Thymic Carcinoi... VIP-Producing N... Well Differenti... Zollinger Ellis...	Capecitabine Temozolomide Veliparib Pharmacological... Laboratory Biom...	18 Years -	Vanderbilt-Ingram Cancer Center
Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor	NCT02831179	Functional Panc... Malignant Somat... Merkel Cell Car... Metastatic Adre... Metastatic Carc... Multiple Endocr... Multiple Endocr... Multiple Endocr... Neuroendocrine ... Non-Functional ... Pancreatic Gluc... Pancreatic Insu... Recurrent Adren... Recurrent Adren... Recurrent Merke... Somatostatin-Pr... Stage III Adren... Stage III Thyro... Stage IIIA Merk... Stage IIIB Merk... Stage IV Adrena... Stage IV Merkel... Stage IVA Thyro... Stage IVB Thyro... Stage IVC Thyro... Thymic Carcinoi... VIP-Producing N... Well Differenti... Zollinger Ellis...	Capecitabine Temozolomide Veliparib Pharmacological... Laboratory Biom...	18 Years -	Vanderbilt-Ingram Cancer Center

Spots Global Cancer Trial Database for pancreatic insulinoma