TRIBE-2: a phase III, randomized, open-label, strategy trial in unresectable metastatic colorectal cancer patients by the GONO group
Abstract Background Chemotherapy plus bevacizumab is a standard first-line treatment for unresectable metastatic colorectal cancer patients. Different chemotherapy backbones may be chosen, including one to three drugs, based on patients’ general conditions and comorbidities, treatments’ objectives,...
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| Language: | English |
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BMC
2017-06-01
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| Series: | BMC Cancer |
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| Online Access: | http://link.springer.com/article/10.1186/s12885-017-3360-z |
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| author | Chiara Cremolini Federica Marmorino Fotios Loupakis Gianluca Masi Carlotta Antoniotti Lisa Salvatore Marta Schirripa Luca Boni Vittorina Zagonel Sara Lonardi Giuseppe Aprile Emiliano Tamburini Vincenzo Ricci Monica Ronzoni Filippo Pietrantonio Chiara Valsuani Gianluca Tomasello Alessandro Passardi Giacomo Allegrini Samantha Di Donato Daniele Santini Alfredo Falcone on behalf of all the investigators of the Gruppo Oncologico del Nord Ovest |
| author_facet | Chiara Cremolini Federica Marmorino Fotios Loupakis Gianluca Masi Carlotta Antoniotti Lisa Salvatore Marta Schirripa Luca Boni Vittorina Zagonel Sara Lonardi Giuseppe Aprile Emiliano Tamburini Vincenzo Ricci Monica Ronzoni Filippo Pietrantonio Chiara Valsuani Gianluca Tomasello Alessandro Passardi Giacomo Allegrini Samantha Di Donato Daniele Santini Alfredo Falcone on behalf of all the investigators of the Gruppo Oncologico del Nord Ovest |
| author_sort | Chiara Cremolini |
| collection | DOAJ |
| description | Abstract Background Chemotherapy plus bevacizumab is a standard first-line treatment for unresectable metastatic colorectal cancer patients. Different chemotherapy backbones may be chosen, including one to three drugs, based on patients’ general conditions and comorbidities, treatments’ objectives, and disease characteristics. TRIBE trial demonstrated a significant advantage in terms of progression-free survival and overall survival for FOLFOXIRI plus bevacizumab as compared with FOLFIRI plus bevacizumab. Based on recent evidence, the de-intensification of the upfront regimen after 4–6 months of treatment is nowadays regarded as a valuable option. Moreover, the prolonged inhibition of angiogenesis, and in particular the continuation of bevacizumab beyond the evidence of disease progression, is an efficacious strategy in the treatment of metastatic colorectal cancer patients. Methods/design TRIBE-2 is a prospective, open-label, multicentric phase III randomized trial in which unresectable and previously untreated metastatic colorectal cancer patients are randomized to receive first-line FOLFOX plus bevacizumab followed by FOLFIRI plus bevacizumab after disease progression or FOLFOXIRI plus bevacizumab followed by the re-introduction of the same regimen after disease progression. The primary endpoint is to compare the efficacy of the two proposed treatment strategies in terms of Progression Free Survival 2. Discussion The TRIBE-2 study aims at answering the question whether the upfront use of FOLFOXIRI improves the clinical outcome of metastatic colorectal cancer patients, when compared with the pre-planned, sequential use of oxaliplatin-based and irinotecan-based doublets. Both proposed treatment strategies are designed to exploit the effectiveness of the prolonged inhibition of angiogenesis, alternating short (up to 4 months) induction periods and less intensive maintenance phases. Trial registration TRIBE2 is registered at Clinicaltrials.gov: NCT02339116 . January 12, 2015. TRIBE-2 is registered at EUDRACT 2014–004436-19, October 10, 2014. |
| first_indexed | 2024-12-11T00:19:25Z |
| format | Article |
| id | doaj.art-1a0fb5b337924a1fba12ac54e2cae3ab |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-11T00:19:25Z |
| publishDate | 2017-06-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-1a0fb5b337924a1fba12ac54e2cae3ab2022-12-22T01:27:48ZengBMCBMC Cancer1471-24072017-06-011711810.1186/s12885-017-3360-zTRIBE-2: a phase III, randomized, open-label, strategy trial in unresectable metastatic colorectal cancer patients by the GONO groupChiara Cremolini0Federica Marmorino1Fotios Loupakis2Gianluca Masi3Carlotta Antoniotti4Lisa Salvatore5Marta Schirripa6Luca Boni7Vittorina Zagonel8Sara Lonardi9Giuseppe Aprile10Emiliano Tamburini11Vincenzo Ricci12Monica Ronzoni13Filippo Pietrantonio14Chiara Valsuani15Gianluca Tomasello16Alessandro Passardi17Giacomo Allegrini18Samantha Di Donato19Daniele Santini20Alfredo Falcone21on behalf of all the investigators of the Gruppo Oncologico del Nord OvestDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 UniversitariaDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 UniversitariaDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 UniversitariaDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 UniversitariaDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 UniversitariaDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 UniversitariaDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 UniversitariaCentro per il Coordinamento per le Sperimentazioni Cliniche, Istituto Toscano Tumori, AOU CareggiOncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)Dipartimento di Oncologia, Azienda Ospedaliero-Universitaria Santa Maria della MisericordiaOspedale InfermiOncologia Medica, Dipartimento di Oncologia Clinica, Azienda Sanitaria Ospedaliera S. CroceOspedale San RaffaeleFondazione I.R.C.C.S, Istituto Nazionale dei TumoriDipartimento Oncologico, A.S.L. 1 CarraraSC Oncologia, Istituti Ospedalieri Di CremonaDipartimento di Oncologia Medica, IRCCS-IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori)Oncologia Medica, Ospedale Felice LottiDipartimento Oncologico, AUSL 4 PratoOncologia Medica, Università Campus Bio-MedicoDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 UniversitariaAbstract Background Chemotherapy plus bevacizumab is a standard first-line treatment for unresectable metastatic colorectal cancer patients. Different chemotherapy backbones may be chosen, including one to three drugs, based on patients’ general conditions and comorbidities, treatments’ objectives, and disease characteristics. TRIBE trial demonstrated a significant advantage in terms of progression-free survival and overall survival for FOLFOXIRI plus bevacizumab as compared with FOLFIRI plus bevacizumab. Based on recent evidence, the de-intensification of the upfront regimen after 4–6 months of treatment is nowadays regarded as a valuable option. Moreover, the prolonged inhibition of angiogenesis, and in particular the continuation of bevacizumab beyond the evidence of disease progression, is an efficacious strategy in the treatment of metastatic colorectal cancer patients. Methods/design TRIBE-2 is a prospective, open-label, multicentric phase III randomized trial in which unresectable and previously untreated metastatic colorectal cancer patients are randomized to receive first-line FOLFOX plus bevacizumab followed by FOLFIRI plus bevacizumab after disease progression or FOLFOXIRI plus bevacizumab followed by the re-introduction of the same regimen after disease progression. The primary endpoint is to compare the efficacy of the two proposed treatment strategies in terms of Progression Free Survival 2. Discussion The TRIBE-2 study aims at answering the question whether the upfront use of FOLFOXIRI improves the clinical outcome of metastatic colorectal cancer patients, when compared with the pre-planned, sequential use of oxaliplatin-based and irinotecan-based doublets. Both proposed treatment strategies are designed to exploit the effectiveness of the prolonged inhibition of angiogenesis, alternating short (up to 4 months) induction periods and less intensive maintenance phases. Trial registration TRIBE2 is registered at Clinicaltrials.gov: NCT02339116 . January 12, 2015. TRIBE-2 is registered at EUDRACT 2014–004436-19, October 10, 2014.http://link.springer.com/article/10.1186/s12885-017-3360-zColorectal cancerBevacizumabStrategyFolfoxiriClinical trial |
| spellingShingle | Chiara Cremolini Federica Marmorino Fotios Loupakis Gianluca Masi Carlotta Antoniotti Lisa Salvatore Marta Schirripa Luca Boni Vittorina Zagonel Sara Lonardi Giuseppe Aprile Emiliano Tamburini Vincenzo Ricci Monica Ronzoni Filippo Pietrantonio Chiara Valsuani Gianluca Tomasello Alessandro Passardi Giacomo Allegrini Samantha Di Donato Daniele Santini Alfredo Falcone on behalf of all the investigators of the Gruppo Oncologico del Nord Ovest TRIBE-2: a phase III, randomized, open-label, strategy trial in unresectable metastatic colorectal cancer patients by the GONO group BMC Cancer Colorectal cancer Bevacizumab Strategy Folfoxiri Clinical trial |
| title | TRIBE-2: a phase III, randomized, open-label, strategy trial in unresectable metastatic colorectal cancer patients by the GONO group |
| title_full | TRIBE-2: a phase III, randomized, open-label, strategy trial in unresectable metastatic colorectal cancer patients by the GONO group |
| title_fullStr | TRIBE-2: a phase III, randomized, open-label, strategy trial in unresectable metastatic colorectal cancer patients by the GONO group |
| title_full_unstemmed | TRIBE-2: a phase III, randomized, open-label, strategy trial in unresectable metastatic colorectal cancer patients by the GONO group |
| title_short | TRIBE-2: a phase III, randomized, open-label, strategy trial in unresectable metastatic colorectal cancer patients by the GONO group |
| title_sort | tribe 2 a phase iii randomized open label strategy trial in unresectable metastatic colorectal cancer patients by the gono group |
| topic | Colorectal cancer Bevacizumab Strategy Folfoxiri Clinical trial |
| url | http://link.springer.com/article/10.1186/s12885-017-3360-z |
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