Design of a randomized controlled phase III study of dose dense methotrexate, vinblastine, doxorubicin and cisplatin (dd-MVAC) or gemcitabine and cisplatin (GC) as peri-operative chemotherapy for patients with locally advanced transitional cell cancer of the bladder. The French GETUG/AFU V05 VESPER trial
The main objective of the French GETUG/AFU V05 VESPER randomized phase III study was to assess the efficacy of dd-MVAC and GC in term of progression-free survival in patients for whom chemotherapy has been decided, before or after surgery.A total of 500 patients have been randomized in 28 reference...
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Format: | Article |
Language: | English |
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Elsevier
2020-03-01
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Series: | Contemporary Clinical Trials Communications |
Online Access: | http://www.sciencedirect.com/science/article/pii/S245186542030020X |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Christian Pfister Valentin Harter Yves Allory François Radvanyi Stéphane Culine G. Grawis G. Pignot A. Flechon J.P. Fendler C. Chevreau M. Soulie H. Mahammedi L. Guy B. Laguerre G. Verhoest A. Guillot N. Mottet F. Joly A. Doerfler S. Abadie-Lacourtoisie A.R. Azzouzi P. Mongiat L. Geoffrois P. Eschwege F. Di Fiore G. Roubaud J.L. Hoepffner P. Barthelemy H. Lang E. Voog E. Mandron J.M. Tourani C. Serrrate A. Colau C. Saldana A. de La Taille T. Nguyen F. Kleinclauss Y. Loriot J. Irani J.C. Eymard S. Larre O. Huillard M. Zerbib F. Rolland J. Rigaud N. Houede S. Droupy G. Malouf M. Roupret M. El Demery C. Legon S. Vieillot N. Letang T. Lharidon N. Gaschignard W. Hilgers J.L. Davin |
spellingShingle |
Christian Pfister Valentin Harter Yves Allory François Radvanyi Stéphane Culine G. Grawis G. Pignot A. Flechon J.P. Fendler C. Chevreau M. Soulie H. Mahammedi L. Guy B. Laguerre G. Verhoest A. Guillot N. Mottet F. Joly A. Doerfler S. Abadie-Lacourtoisie A.R. Azzouzi P. Mongiat L. Geoffrois P. Eschwege F. Di Fiore G. Roubaud J.L. Hoepffner P. Barthelemy H. Lang E. Voog E. Mandron J.M. Tourani C. Serrrate A. Colau C. Saldana A. de La Taille T. Nguyen F. Kleinclauss Y. Loriot J. Irani J.C. Eymard S. Larre O. Huillard M. Zerbib F. Rolland J. Rigaud N. Houede S. Droupy G. Malouf M. Roupret M. El Demery C. Legon S. Vieillot N. Letang T. Lharidon N. Gaschignard W. Hilgers J.L. Davin Design of a randomized controlled phase III study of dose dense methotrexate, vinblastine, doxorubicin and cisplatin (dd-MVAC) or gemcitabine and cisplatin (GC) as peri-operative chemotherapy for patients with locally advanced transitional cell cancer of the bladder. The French GETUG/AFU V05 VESPER trial Contemporary Clinical Trials Communications |
author_facet |
Christian Pfister Valentin Harter Yves Allory François Radvanyi Stéphane Culine G. Grawis G. Pignot A. Flechon J.P. Fendler C. Chevreau M. Soulie H. Mahammedi L. Guy B. Laguerre G. Verhoest A. Guillot N. Mottet F. Joly A. Doerfler S. Abadie-Lacourtoisie A.R. Azzouzi P. Mongiat L. Geoffrois P. Eschwege F. Di Fiore G. Roubaud J.L. Hoepffner P. Barthelemy H. Lang E. Voog E. Mandron J.M. Tourani C. Serrrate A. Colau C. Saldana A. de La Taille T. Nguyen F. Kleinclauss Y. Loriot J. Irani J.C. Eymard S. Larre O. Huillard M. Zerbib F. Rolland J. Rigaud N. Houede S. Droupy G. Malouf M. Roupret M. El Demery C. Legon S. Vieillot N. Letang T. Lharidon N. Gaschignard W. Hilgers J.L. Davin |
author_sort |
Christian Pfister |
title |
Design of a randomized controlled phase III study of dose dense methotrexate, vinblastine, doxorubicin and cisplatin (dd-MVAC) or gemcitabine and cisplatin (GC) as peri-operative chemotherapy for patients with locally advanced transitional cell cancer of the bladder. The French GETUG/AFU V05 VESPER trial |
title_short |
Design of a randomized controlled phase III study of dose dense methotrexate, vinblastine, doxorubicin and cisplatin (dd-MVAC) or gemcitabine and cisplatin (GC) as peri-operative chemotherapy for patients with locally advanced transitional cell cancer of the bladder. The French GETUG/AFU V05 VESPER trial |
title_full |
Design of a randomized controlled phase III study of dose dense methotrexate, vinblastine, doxorubicin and cisplatin (dd-MVAC) or gemcitabine and cisplatin (GC) as peri-operative chemotherapy for patients with locally advanced transitional cell cancer of the bladder. The French GETUG/AFU V05 VESPER trial |
title_fullStr |
Design of a randomized controlled phase III study of dose dense methotrexate, vinblastine, doxorubicin and cisplatin (dd-MVAC) or gemcitabine and cisplatin (GC) as peri-operative chemotherapy for patients with locally advanced transitional cell cancer of the bladder. The French GETUG/AFU V05 VESPER trial |
title_full_unstemmed |
Design of a randomized controlled phase III study of dose dense methotrexate, vinblastine, doxorubicin and cisplatin (dd-MVAC) or gemcitabine and cisplatin (GC) as peri-operative chemotherapy for patients with locally advanced transitional cell cancer of the bladder. The French GETUG/AFU V05 VESPER trial |
title_sort |
design of a randomized controlled phase iii study of dose dense methotrexate, vinblastine, doxorubicin and cisplatin (dd-mvac) or gemcitabine and cisplatin (gc) as peri-operative chemotherapy for patients with locally advanced transitional cell cancer of the bladder. the french getug/afu v05 vesper trial |
publisher |
Elsevier |
series |
Contemporary Clinical Trials Communications |
issn |
2451-8654 |
publishDate |
2020-03-01 |
description |
The main objective of the French GETUG/AFU V05 VESPER randomized phase III study was to assess the efficacy of dd-MVAC and GC in term of progression-free survival in patients for whom chemotherapy has been decided, before or after surgery.A total of 500 patients have been randomized in 28 reference centers. Inclusion criteria were urothelial carcinoma without neuro-endocrine variant, disease defined by a T2, T3 or T4a N0 (pelvic lymph node ≤ 10 mm on CT scan) M0 staging for patients receiving neoadjuvant chemotherapy or pT3 or pT4 or pN+ and M0 for patients receiving adjuvant chemotherapy. Secondary endpoints include overall survival, safety, response rate. The peri-operative chemotherapy schedule was experimental arm dd-MVAC for a total of 6 cycles versus standard arm GC 4 cycles. The toxicity was evaluated according to NCI CTCAE (v 4.0). The progression-free survival rate will be estimated at 3 years by the Kaplan-Meier method. All the patients will be followed for 5 years.The last patient was randomized in March 2018 and the primary endpoint results are expected for mid-2021. As the dd-MVAC schedule is associated with higher response rates in metastatic disease, the real question today is to confirm such benefit in the peri-operative setting, taking also in consideration the chemotherapy toxicity. Tomorrow, the challenge may be the best chemotherapy and immunotherapy association, the authors hope that final Vesper Trial results will help to determine the gold standard chemotherapy. Keywords: Bladder cancer, Peri-operative chemotherapy |
url |
http://www.sciencedirect.com/science/article/pii/S245186542030020X |
work_keys_str_mv |
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doaj-f43ed578297242ffbca2d23538b428ab2020-11-25T02:19:41ZengElsevierContemporary Clinical Trials Communications2451-86542020-03-0117Design of a randomized controlled phase III study of dose dense methotrexate, vinblastine, doxorubicin and cisplatin (dd-MVAC) or gemcitabine and cisplatin (GC) as peri-operative chemotherapy for patients with locally advanced transitional cell cancer of the bladder. The French GETUG/AFU V05 VESPER trialChristian Pfister0Valentin Harter1Yves Allory2François Radvanyi3Stéphane Culine4G. Grawis5G. Pignot6A. Flechon7J.P. Fendler8C. Chevreau9M. Soulie10H. Mahammedi11L. Guy12B. Laguerre13G. Verhoest14A. Guillot15N. Mottet16F. Joly17A. Doerfler18S. Abadie-Lacourtoisie19A.R. Azzouzi20P. Mongiat21L. Geoffrois22P. Eschwege23F. Di Fiore24G. Roubaud25J.L. Hoepffner26P. Barthelemy27H. Lang28E. Voog29E. Mandron30J.M. Tourani31C. Serrrate32A. Colau33C. Saldana34A. de La Taille35T. Nguyen36F. Kleinclauss37Y. Loriot38J. Irani39J.C. Eymard40S. Larre41O. Huillard42M. Zerbib43F. Rolland44J. Rigaud45N. Houede46S. Droupy47G. Malouf48M. Roupret49M. El Demery50C. Legon51S. Vieillot52N. Letang53T. Lharidon54N. Gaschignard55W. Hilgers56J.L. Davin57Department of Urology, Rouen University Hospital, Rouen, France; Clinical Investigation Center, Inserm 6204, Onco-Urology, Rouen, France; Corresponding author. Urology Department, Charles Nicolle Rouen University Hospital, 1 rue de Germont, 76031, Rouen Cedex, France.Department of Biostatistics, Baclesse Unicancer Center, Caen, FranceDepartment of Pathology, Institut Curie, Saint-Cloud, FranceUMR144 CNRS Laboratory, Institut Curie, Paris, FranceDepartment of Medical Oncology, Saint-Louis, APHP, Paris, FranceMarseille, FranceMarseille, FranceLyon, FranceLyon, FranceToulouse, FranceToulouse, FranceClermont-Ferrand, FranceClermont-Ferrand, FranceRennes, FranceRennes, FranceSaint-Etienne, FranceSaint-Etienne, FranceCaen, FranceCaen, FranceAngers, FranceAngers, FranceSaint-Louis, Paris, FranceNancy, FranceNancy, FranceRouen, FranceBordeaux, FranceBordeaux, FranceStrasbourg, FranceStrasbourg, FranceLe Mans, FranceLe Mans, FrancePoitiers, FranceDiaconesses, Paris, FranceDiaconesses, Paris, FranceMondor, Paris, FranceMondor, Paris, FranceBesançon, FranceBesançon, FranceVillejuif, FranceVillejuif, FranceReims, FranceReims, FranceCochin, IndiaCochin, IndiaNantes, FranceNantes, FranceNimes, FranceNimes, FrancePitié-Salpetrière, Paris, FrancePitié-Salpetrière, Paris, FranceLa Seyne sur Mer, FranceLa Seyne sur Mer, FrancePerpignan, FrancePerpignan, FranceLa Roche sur Yon, FranceLa Roche sur Yon, FranceAvignon, FranceAvignon, FranceThe main objective of the French GETUG/AFU V05 VESPER randomized phase III study was to assess the efficacy of dd-MVAC and GC in term of progression-free survival in patients for whom chemotherapy has been decided, before or after surgery.A total of 500 patients have been randomized in 28 reference centers. Inclusion criteria were urothelial carcinoma without neuro-endocrine variant, disease defined by a T2, T3 or T4a N0 (pelvic lymph node ≤ 10 mm on CT scan) M0 staging for patients receiving neoadjuvant chemotherapy or pT3 or pT4 or pN+ and M0 for patients receiving adjuvant chemotherapy. Secondary endpoints include overall survival, safety, response rate. The peri-operative chemotherapy schedule was experimental arm dd-MVAC for a total of 6 cycles versus standard arm GC 4 cycles. The toxicity was evaluated according to NCI CTCAE (v 4.0). The progression-free survival rate will be estimated at 3 years by the Kaplan-Meier method. All the patients will be followed for 5 years.The last patient was randomized in March 2018 and the primary endpoint results are expected for mid-2021. As the dd-MVAC schedule is associated with higher response rates in metastatic disease, the real question today is to confirm such benefit in the peri-operative setting, taking also in consideration the chemotherapy toxicity. Tomorrow, the challenge may be the best chemotherapy and immunotherapy association, the authors hope that final Vesper Trial results will help to determine the gold standard chemotherapy. Keywords: Bladder cancer, Peri-operative chemotherapyhttp://www.sciencedirect.com/science/article/pii/S245186542030020X |