An open-label, single-arm pilot study of EUS-guided brachytherapy with phosphorus-32 microparticles in combination with gemcitabine +/- nab-paclitaxel in unresectable locally advanced pancreatic cancer (OncoPaC-1): Technical details and study protocol

Manoop S Bhutani; Jason B Klapman; Richard Tuli; Ghassan El-Haddad; Sarah Hoffe; Franklin C L Wong; Beth Chasen; David R Fogelman; Simon K Lo; Nicholas N Nissen; Andrew E Hendifar; Gauri Varadhachary; Matthew H G Katz; William D Erwin; Eugene J Koay; Eric P Tamm; Ben S Singh; Rutika Mehta; Robert A Wolff; Ashish Soman; Irina M Cazacu; Joseph M Herman

doi:10.4103/eus.eus_44_19

An open-label, single-arm pilot study of EUS-guided brachytherapy with phosphorus-32 microparticles in combination with gemcitabine +/- nab-paclitaxel in unresectable locally advanced pancreatic cancer (OncoPaC-1): Technical details and study protocol

Endosc Ultrasound. 2020 Jan-Feb;9(1):24-30. doi: 10.4103/eus.eus_44_19.

Authors

Manoop S Bhutani¹, Jason B Klapman², Richard Tuli³, Ghassan El-Haddad⁴, Sarah Hoffe⁵, Franklin C L Wong⁶, Beth Chasen⁶, David R Fogelman⁷, Simon K Lo⁸, Nicholas N Nissen⁹, Andrew E Hendifar¹⁰, Gauri Varadhachary⁷, Matthew H G Katz¹¹, William D Erwin¹², Eugene J Koay¹³, Eric P Tamm¹⁴, Ben S Singh¹, Rutika Mehta², Robert A Wolff⁷, Ashish Soman¹⁵, Irina M Cazacu¹, Joseph M Herman¹³

Affiliations

¹ Department of Gastroenterology, Hepatology and Nutrition, Houston, TX, USA.
² Department of Gastrointestinal Oncology, Moffitt Cancer Center, Tampa, FL, USA.
³ Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
⁴ Department of Diagnostic Imaging and Interventional Radiology, Moffitt Cancer Center, Tampa, FL, USA.
⁵ Department of Radiation Oncology, Moffitt Cancer Center, Tampa, FL, USA.
⁶ Department of Nuclear Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁷ Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁸ Division of Digestive and Liver Diseases, Cedars Sinai Medical Center, Los Angeles, CA, USA.
⁹ Department of Surgery, Cedars Sinai Medical Center, Los Angeles, CA, USA.
¹⁰ Department of Hematology/Oncology, Cedars Sinai Medical Center, Los Angeles, CA, USA.
¹¹ Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
¹² Department of Imaging Physics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
¹³ Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
¹⁴ Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
¹⁵ Department of OncoSil Medical Ltd., Sydney, Australia.

Abstract

Current treatment options for patients with unresectable locally advanced pancreatic cancer (LAPC) include chemotherapy alone or followed by chemoradiation or stereotactic body radiotherapy. However, the prognosis for these patients remains poor, with a median overall survival <12 months. Therefore, novel treatment options are needed. Currently, there is no brachytherapy device approved for pancreatic cancer treatment. Hereby, we present the protocol of a prospective, multicenter, interventional, open-label, single-arm pilot study (OncoPac-1, Clinicaltrial.gov-NCT03076216) aiming to determine the safety and efficacy of Phosphorus-32 when implanted directly into pancreatic tumors using EUS guidance, for patients with unresectable LAPC undergoing chemotherapy (gemcitabine ± nab-paclitaxel).

Keywords: Brachytherapy; EUS; chemotherapy; endoscopy; fine needle injection; intratumoral therapy; neoplasia; pancreatic cancer; phosphorus-32; radiotherapy.

Grants and funding

UL1 TR003167/TR/NCATS NIH HHS/United States