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

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 SomanIrina M. Cazacu, Joseph M. Herman

Research output: Contribution to journal › Article › peer-review

20 Scopus citations

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).

Original language	English (US)
Pages (from-to)	24-30
Number of pages	7
Journal	Endoscopic Ultrasound
Volume	9
Issue number	1
DOIs	https://doi.org/10.4103/eus.eus_44_19
State	Published - Jan 1 2020

Keywords

Brachytherapy
Chemotherapy
EUS
Endoscopy
Fine needle injection
Intratumoral therapy
Neoplasia
Pancreatic cancer
Phosphorus-32
Radiotherapy

ASJC Scopus subject areas

Hepatology
Radiology Nuclear Medicine and imaging
Gastroenterology

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Bhutani, M. S., Klapman, J. B., Tuli, R., El-Haddad, G., Hoffe, S., Wong, F. C. L., Chasen, B., Fogelman, D. R., Lo, S. K., Nissen, N. N., Hendifar, A. E., Varadhachary, G., Katz, M. H. G., Erwin, W. D., Koay, E. J., Tamm, E. P., Singh, B. S., Mehta, R., Wolff, R. A., ... Herman, J. M. (2020). 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. Endoscopic Ultrasound, 9(1), 24-30. https://doi.org/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. / Bhutani, Manoop S.; Klapman, Jason B.; Tuli, Richard et al.
In: Endoscopic Ultrasound, Vol. 9, No. 1, 01.01.2020, p. 24-30.

Research output: Contribution to journal › Article › peer-review

Bhutani, MS, Klapman, JB, Tuli, R, El-Haddad, G, Hoffe, S, Wong, FCL , Chasen, B, Fogelman, DR, Lo, SK, Nissen, NN, Hendifar, AE, Varadhachary, G, Katz, MHG , Erwin, WD , Koay, EJ , Tamm, EP, Singh, BS, Mehta, R, Wolff, RA, Soman, A, Cazacu, IM & Herman, JM 2020, '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', Endoscopic Ultrasound, vol. 9, no. 1, pp. 24-30. https://doi.org/10.4103/eus.eus_44_19

Bhutani MS, Klapman JB, Tuli R, El-Haddad G, Hoffe S, Wong FCL et al. 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. Endoscopic Ultrasound. 2020 Jan 1;9(1):24-30. doi: 10.4103/eus.eus_44_19

Bhutani, Manoop S. ; Klapman, Jason B. ; Tuli, Richard et al. / 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. In: Endoscopic Ultrasound. 2020 ; Vol. 9, No. 1. pp. 24-30.

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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, Chemotherapy, EUS, Endoscopy, Fine needle injection, Intratumoral therapy, Neoplasia, Pancreatic cancer, Phosphorus-32, Radiotherapy",

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AU - Erwin, William D.

AU - Koay, Eugene J.

AU - Tamm, Eric P.

AU - Singh, Ben S.

AU - Mehta, Rutika

AU - Wolff, Robert A.

AU - Soman, Ashish

AU - Cazacu, Irina M.

AU - Herman, Joseph M.

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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

Abstract

Keywords

ASJC Scopus subject areas

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