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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


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

Correspondence Address:
Joseph M Herman,
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, T. Boone Pickens Academic Tower (FCT6.6080), 1515 Holcombe Blvd., Unit 1442, Houston, Texas 77030
USA
Manoop S Bhutani,
Department of Gastroenterology, Hepatology and Nutrition, The University of Texas Anderson Cancer Center, 1515 Holcombe Blvd., Houston 77030-4009, Texas
USA
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/eus.eus_44_19

PMID: 31670288

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).


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    -  Bhutani MS
    -  Klapman JB
    -  Tuli R
    -  El-Haddad G
    -  Hoffe S
    -  Wong FC
    -  Chasen B
    -  Fogelman DR
    -  Lo SK
    -  Nissen NN
    -  Hendifar AE
    -  Varadhachary G
    -  Katz MH
    -  Erwin WD
    -  Koay EJ
    -  Tamm EP
    -  Singh BS
    -  Mehta R
    -  Wolff RA
    -  Soman A
    -  Cazacu IM
    -  Herman JM
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