Cargando…
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
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. Therefo...
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Wolters Kluwer - Medknow
2019
|
| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7038730/ https://www.ncbi.nlm.nih.gov/pubmed/31670288 http://dx.doi.org/10.4103/eus.eus_44_19 |
| _version_ | 1783500701614211072 |
|---|---|
| author | Bhutani, Manoop S. Klapman, Jason B. Tuli, Richard El-Haddad, Ghassan Hoffe, Sarah Wong, Franklin C. L. Chasen, Beth Fogelman, David R. Lo, Simon K. Nissen, Nicholas N. Hendifar, Andrew E. Varadhachary, Gauri Katz, Matthew H. G. Erwin, William D. Koay, Eugene J. Tamm, Eric P. Singh, Ben S. Mehta, Rutika Wolff, Robert A. Soman, Ashish Cazacu, Irina M. Herman, Joseph M. |
| author_facet | Bhutani, Manoop S. Klapman, Jason B. Tuli, Richard El-Haddad, Ghassan Hoffe, Sarah Wong, Franklin C. L. Chasen, Beth Fogelman, David R. Lo, Simon K. Nissen, Nicholas N. Hendifar, Andrew E. Varadhachary, Gauri Katz, Matthew H. G. Erwin, William D. Koay, Eugene J. Tamm, Eric P. Singh, Ben S. Mehta, Rutika Wolff, Robert A. Soman, Ashish Cazacu, Irina M. Herman, Joseph M. |
| author_sort | Bhutani, Manoop S. |
| collection | PubMed |
| description | 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). |
| format | Online Article Text |
| id | pubmed-7038730 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2019 |
| publisher | Wolters Kluwer - Medknow |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-70387302020-03-12 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 El-Haddad, Ghassan Hoffe, Sarah Wong, Franklin C. L. Chasen, Beth Fogelman, David R. Lo, Simon K. Nissen, Nicholas N. Hendifar, Andrew E. Varadhachary, Gauri Katz, Matthew H. G. Erwin, William D. Koay, Eugene J. Tamm, Eric P. Singh, Ben S. Mehta, Rutika Wolff, Robert A. Soman, Ashish Cazacu, Irina M. Herman, Joseph M. Endosc Ultrasound Rapid Communication 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). Wolters Kluwer - Medknow 2019-10-30 /pmc/articles/PMC7038730/ /pubmed/31670288 http://dx.doi.org/10.4103/eus.eus_44_19 Text en Copyright: © 2019 Spring Media Publishing Co. Ltd http://creativecommons.org/licenses/by-nc-sa/4.0 This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms. |
| spellingShingle | Rapid Communication Bhutani, Manoop S. Klapman, Jason B. Tuli, Richard El-Haddad, Ghassan Hoffe, Sarah Wong, Franklin C. L. Chasen, Beth Fogelman, David R. Lo, Simon K. Nissen, Nicholas N. Hendifar, Andrew E. Varadhachary, Gauri Katz, Matthew H. G. Erwin, William D. Koay, Eugene J. Tamm, Eric P. Singh, Ben S. Mehta, Rutika Wolff, Robert A. Soman, Ashish Cazacu, Irina M. Herman, Joseph M. 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Rapid Communication |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7038730/ https://www.ncbi.nlm.nih.gov/pubmed/31670288 http://dx.doi.org/10.4103/eus.eus_44_19 |
| work_keys_str_mv | AT bhutanimanoops anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT klapmanjasonb anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT tulirichard anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT elhaddadghassan anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT hoffesarah anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT wongfranklincl anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT chasenbeth anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT fogelmandavidr anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT losimonk anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT nissennicholasn anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT hendifarandrewe anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT varadhacharygauri anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT katzmatthewhg anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT erwinwilliamd anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT koayeugenej anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT tammericp anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT singhbens anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT mehtarutika anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT wolffroberta anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT somanashish anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT cazacuirinam anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT hermanjosephm anopenlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT bhutanimanoops openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT klapmanjasonb openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT tulirichard openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT elhaddadghassan openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT hoffesarah openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT wongfranklincl openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT chasenbeth openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT fogelmandavidr openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT losimonk openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT nissennicholasn openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT hendifarandrewe openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT varadhacharygauri openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT katzmatthewhg openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT erwinwilliamd openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT koayeugenej openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT tammericp openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT singhbens openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT mehtarutika openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT wolffroberta openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT somanashish openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT cazacuirinam openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol AT hermanjosephm openlabelsinglearmpilotstudyofeusguidedbrachytherapywithphosphorus32microparticlesincombinationwithgemcitabinenabpaclitaxelinunresectablelocallyadvancedpancreaticcanceroncopac1technicaldetailsandstudyprotocol |