Hypofractionated helical intensity-modulated radiotherapy of the prostate bed after prostatectomy with or without the pelvic lymph nodes - the PRIAMOS trial
Identifieur interne : 004256 ( Main/Exploration ); précédent : 004255; suivant : 004257Hypofractionated helical intensity-modulated radiotherapy of the prostate bed after prostatectomy with or without the pelvic lymph nodes - the PRIAMOS trial
Auteurs : Sonja Krause [Allemagne] ; Florian Sterzing [Allemagne] ; Dirk Neuhof [Allemagne] ; Lutz Edler [Allemagne] ; Juergen Debus [Allemagne] ; Klaus Herfarth [Allemagne]Source :
- BMC Cancer [ 1471-2407 ] ; 2012.
Abstract
While evidence on safety and efficacy of primary hypofractionated radiotherapy in prostate cancer is accumulating, data on postoperative hypofractionated treatment of the prostate bed and of the pelvic lymph nodes is still scarce. This phase II trial was initiated to investigate safety and feasibility of hypofractionated treatment of the prostate bed alone or with the pelvic lymph nodes.
A total of 80 prostate cancer patients with the indication for adjuvant radiotherapy will be enrolled, where 40 patients with a low risk of lymph node involvement (arm 1) and another 40 patients with a high risk of lymph node involvement (arm 2) will each receive 54 Gy in 18 fractions to the prostate bed. Arm 2 will be given 45 Gy to the pelvic lymph nodes additionally. Helical Tomotherapy and daily image guidance will be used.
This trial was initiated to substantiate data on hypofractionated treatment of the prostate bed and generate first data on adjuvant hypofractionated radiotherapy of the pelvic lymph nodes.
ClinicalTrials.gov; NCT01620710
Url:
DOI: 10.1186/1471-2407-12-504
PubMed: 23114055
PubMed Central: 3495015
Affiliations:
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Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Sterzing, Florian" sort="Sterzing, Florian" uniqKey="Sterzing F" first="Florian" last="Sterzing">Florian Sterzing</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Neuhof, Dirk" sort="Neuhof, Dirk" uniqKey="Neuhof D" first="Dirk" last="Neuhof">Dirk Neuhof</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Edler, Lutz" sort="Edler, Lutz" uniqKey="Edler L" first="Lutz" last="Edler">Lutz Edler</name><affiliation wicri:level="3"><nlm:aff id="I2">Department of Biostatistics, German Cancer Research Center, Im Neuenheimer Feld 280, 69120, Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Biostatistics, German Cancer Research Center, Im Neuenheimer Feld 280, 69120, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Debus, Juergen" sort="Debus, Juergen" uniqKey="Debus J" first="Juergen" last="Debus">Juergen Debus</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Herfarth, Klaus" sort="Herfarth, Klaus" uniqKey="Herfarth K" first="Klaus" last="Herfarth">Klaus Herfarth</name><affiliation wicri:level="3"><nlm:aff id="I2">Department of Biostatistics, German Cancer Research Center, Im Neuenheimer Feld 280, 69120, Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Biostatistics, German Cancer Research Center, Im Neuenheimer Feld 280, 69120, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author></analytic><series><title level="j">BMC Cancer</title><idno type="eISSN">1471-2407</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>While evidence on safety and efficacy of primary hypofractionated radiotherapy in prostate cancer is accumulating, data on postoperative hypofractionated treatment of the prostate bed and of the pelvic lymph nodes is still scarce. This phase II trial was initiated to investigate safety and feasibility of hypofractionated treatment of the prostate bed alone or with the pelvic lymph nodes.</p></sec><sec><title>Methods/design</title><p>A total of 80 prostate cancer patients with the indication for adjuvant radiotherapy will be enrolled, where 40 patients with a low risk of lymph node involvement (arm 1) and another 40 patients with a high risk of lymph node involvement (arm 2) will each receive 54 Gy in 18 fractions to the prostate bed. Arm 2 will be given 45 Gy to the pelvic lymph nodes additionally. Helical Tomotherapy and daily image guidance will be used.</p></sec><sec><title>Discussion</title><p>This trial was initiated to substantiate data on hypofractionated treatment of the prostate bed and generate first data on adjuvant hypofractionated radiotherapy of the pelvic lymph nodes.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials.gov; NCT01620710</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Rollig, C" uniqKey="Rollig C">C Röllig</name></author><author><name sortKey="Nothacker, M" uniqKey="Nothacker M">M Nothacker</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Stephenson, Aj" uniqKey="Stephenson A">AJ Stephenson</name></author><author><name sortKey="Scardino, Pt" uniqKey="Scardino P">PT Scardino</name></author><author><name sortKey="Kattan, Mw" uniqKey="Kattan M">MW Kattan</name></author><author><name sortKey="Pisansky, Tm" uniqKey="Pisansky T">TM 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sortKey="Kalz, J" uniqKey="Kalz J">J Kalz</name></author><author><name sortKey="Debus, J" uniqKey="Debus J">J Debus</name></author><author><name sortKey="Herfarth, K" uniqKey="Herfarth K">K Herfarth</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Roach, M" uniqKey="Roach M">M Roach</name></author><author><name sortKey="Marquez, C" uniqKey="Marquez C">C Marquez</name></author><author><name sortKey="Yuo, Hs" uniqKey="Yuo H">HS Yuo</name></author><author><name sortKey="Narayan, P" uniqKey="Narayan P">P Narayan</name></author><author><name sortKey="Coleman, L" uniqKey="Coleman L">L Coleman</name></author><author><name sortKey="Nseyo, Uo" uniqKey="Nseyo U">UO Nseyo</name></author><author><name sortKey="Navvab, Z" uniqKey="Navvab Z">Z Navvab</name></author><author><name sortKey="Carroll, Pr" uniqKey="Carroll P">PR Carroll</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="A Hern, Rp" uniqKey="A Hern R">RP A'Hern</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lawton, Ca" uniqKey="Lawton C">CA Lawton</name></author><author><name sortKey="Michalski, J" uniqKey="Michalski J">J Michalski</name></author><author><name sortKey="El Naqa, I" uniqKey="El Naqa I">I El-Naqa</name></author><author><name sortKey="Byyounouski, Mk" uniqKey="Byyounouski M">MK Byyounouski</name></author><author><name sortKey="Lee, Wr" uniqKey="Lee W">WR Lee</name></author><author><name sortKey="Menard, C" uniqKey="Menard C">C Menard</name></author><author><name sortKey="O Eara, E" uniqKey="O Eara E">E O’Meara</name></author><author><name sortKey="Rosenthal, Sa" uniqKey="Rosenthal S">SA Rosenthal</name></author><author><name sortKey="Ritter, M" uniqKey="Ritter M">M Ritter</name></author><author><name sortKey="Seider, M" uniqKey="Seider M">M Seider</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Martin, Jm" uniqKey="Martin J">JM Martin</name></author><author><name sortKey="Rosewall, T" uniqKey="Rosewall T">T Rosewall</name></author><author><name sortKey="Bayley, A" uniqKey="Bayley A">A Bayley</name></author><author><name sortKey="Bristow, R" uniqKey="Bristow R">R Bristow</name></author><author><name sortKey="Chung, P" uniqKey="Chung P">P Chung</name></author><author><name sortKey="Crook, J" uniqKey="Crook J">J Crook</name></author><author><name sortKey="Gospodarowicz, M" uniqKey="Gospodarowicz M">M Gospodarowicz</name></author><author><name sortKey="Mclean, M" uniqKey="Mclean M">M McLean</name></author><author><name sortKey="Menard, C" uniqKey="Menard C">C Menard</name></author><author><name sortKey="Milosevic, M" uniqKey="Milosevic M">M Milosevic</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cozzarini, C" uniqKey="Cozzarini C">C Cozzarini</name></author><author><name sortKey="Fiorino, C" uniqKey="Fiorino C">C Fiorino</name></author><author><name sortKey="Di Muzio, N" uniqKey="Di Muzio N">N Di Muzio</name></author><author><name sortKey="Valdagni, R" uniqKey="Valdagni R">R Valdagni</name></author><author><name sortKey="Salonia, A" uniqKey="Salonia A">A Salonia</name></author><author><name sortKey="Alongi, F" uniqKey="Alongi F">F Alongi</name></author><author><name sortKey="Broggi, S" uniqKey="Broggi S">S Broggi</name></author><author><name sortKey="Guazzoni, G" uniqKey="Guazzoni G">G Guazzoni</name></author><author><name sortKey="Montorsi, F" uniqKey="Montorsi F">F Montorsi</name></author><author><name sortKey="Rigatti, P" uniqKey="Rigatti P">P Rigatti</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Adkison, Jb" uniqKey="Adkison J">JB Adkison</name></author><author><name sortKey="Mchaffie, Dr" uniqKey="Mchaffie D">DR McHaffie</name></author><author><name sortKey="Bentzen, Sm" uniqKey="Bentzen S">SM Bentzen</name></author><author><name sortKey="Patel, Rr" uniqKey="Patel R">RR Patel</name></author><author><name sortKey="Khuntia, D" uniqKey="Khuntia D">D Khuntia</name></author><author><name sortKey="Petereit, Dg" uniqKey="Petereit D">DG Petereit</name></author><author><name sortKey="Hong, Ts" uniqKey="Hong T">TS Hong</name></author><author><name sortKey="Tome, W" uniqKey="Tome W">W Tome</name></author><author><name sortKey="Ritter, Ma" uniqKey="Ritter M">MA Ritter</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li></country><region><li>Bade-Wurtemberg</li><li>District de Karlsruhe</li></region><settlement><li>Heidelberg</li></settlement></list><tree><country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Krause, Sonja" sort="Krause, Sonja" uniqKey="Krause S" first="Sonja" last="Krause">Sonja Krause</name></region><name sortKey="Debus, Juergen" sort="Debus, Juergen" uniqKey="Debus J" first="Juergen" last="Debus">Juergen Debus</name><name sortKey="Edler, Lutz" sort="Edler, Lutz" uniqKey="Edler L" first="Lutz" last="Edler">Lutz Edler</name><name sortKey="Herfarth, Klaus" sort="Herfarth, Klaus" uniqKey="Herfarth K" first="Klaus" last="Herfarth">Klaus Herfarth</name><name sortKey="Neuhof, Dirk" sort="Neuhof, Dirk" uniqKey="Neuhof D" first="Dirk" last="Neuhof">Dirk Neuhof</name><name sortKey="Sterzing, Florian" sort="Sterzing, Florian" uniqKey="Sterzing F" first="Florian" last="Sterzing">Florian Sterzing</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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