Evidence map›Paper›PMID 28599628›Full record

Trial reportBMC cancer2017

TRIBE-2: a phase III, randomized, open-label, strategy trial in unresectable metastatic colorectal cancer patients by the GONO group.

Chiara Cremolini, Federica Marmorino, Fotios Loupakis, Gianluca Masi, Carlotta Antoniotti, Lisa Salvatore, Marta Schirripa, Luca Boni, Vittorina Zagonel, Sara Lonardi and 13 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in BMC cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02339116 (FIRST-LINE FOLFOXIRI PLUS BEVACIZUMAB FOLLOWED BY REINTRODUCTION OF FOLFOXIRI PLUS BEVACIZUMAB AT PROGRESSION Versus FOLFOX PLUS BEVACIZUMAB FOLLOWED BY FOLFIRI PLUS BEVACIZUMAB AT PROGRESSION IN FIRST- AND SECOND-LINE TREATMENT OF UNRESECTABLE METASTATIC COLORECTAL CANCER.), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02339116 phase3unknown statusnot on this map

FIRST-LINE FOLFOXIRI PLUS BEVACIZUMAB FOLLOWED BY REINTRODUCTION OF FOLFOXIRI PLUS BEVACIZUMAB AT PROGRESSION Versus FOLFOX PLUS BEVACIZUMAB FOLLOWED BY FOLFIRI PLUS BEVACIZUMAB AT PROGRESSION IN FIRST- AND SECOND-LINE TREATMENT OF UNRESECTABLE METASTATIC COLORECTAL CANCER.

TypeinterventionalSponsorGruppo Oncologico del Nord-OvestRan2015 to 2021Enrolled654ConditionsMetastatic Colorectal CancerArmsfluoruracil, Oxaliplatin, Irinotecan, Bevacizumab
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Chiara CremoliniDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 Universitaria, Azienda Ospedaliero-Universitaria Pisana, Via Roma 67, 56126, Pisa, Italy.
Federica MarmorinoDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 Universitaria, Azienda Ospedaliero-Universitaria Pisana, Via Roma 67, 56126, Pisa, Italy.
Fotios LoupakisDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 Universitaria, Azienda Ospedaliero-Universitaria Pisana, Via Roma 67, 56126, Pisa, Italy.
Gianluca MasiDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 Universitaria, Azienda Ospedaliero-Universitaria Pisana, Via Roma 67, 56126, Pisa, Italy.
Carlotta AntoniottiDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 Universitaria, Azienda Ospedaliero-Universitaria Pisana, Via Roma 67, 56126, Pisa, Italy.
Lisa SalvatoreDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 Universitaria, Azienda Ospedaliero-Universitaria Pisana, Via Roma 67, 56126, Pisa, Italy.
Marta SchirripaDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 Universitaria, Azienda Ospedaliero-Universitaria Pisana, Via Roma 67, 56126, Pisa, Italy.
Luca BoniCentro per il Coordinamento per le Sperimentazioni Cliniche, Istituto Toscano Tumori, AOU Careggi, viale Pieraccini 6, 50139, Florence, Italy.
Vittorina ZagonelOncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), via Gattamelata 64, 35128, Padua, Italy.
Sara LonardiOncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), via Gattamelata 64, 35128, Padua, Italy.
Giuseppe AprileDipartimento di Oncologia, Azienda Ospedaliero-Universitaria Santa Maria della Misericordia, Piazzale Santa Maria della Misericordia 15, 33100, Udine, Italy.
Emiliano TamburiniOspedale Infermi, Via Coriano 38, 47924, Rimini, Italy.
Vincenzo RicciOncologia Medica, Dipartimento di Oncologia Clinica, Azienda Sanitaria Ospedaliera S. Croce, Via Michele Coppino 26, 12100, Cuneo, Italy.
Monica RonzoniOspedale San Raffaele, Via Olgettina 60, 20132, Milan, Italy.
Filippo PietrantonioFondazione I.R.C.C.S, Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy.
Chiara ValsuaniDipartimento Oncologico, A.S.L. 1 Carrara, P.zza Sacco e Vanzetti, 2, 54033, Carrara, Italy.
Gianluca TomaselloSC Oncologia, Istituti Ospedalieri Di Cremona, Viale Concordia 1, 26100, Cremona, Italy.
Alessandro PassardiDipartimento di Oncologia Medica, IRCCS-IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori), via Piero Maroncelli 40, 47014, Meldola, FC, Italy.
Giacomo AllegriniOncologia Medica, Ospedale Felice Lotti, via Roma 147, 56025, Pontedera, Italy.
Samantha Di DonatoDipartimento Oncologico, AUSL 4 Prato, Via Mazzamuti 7, 59100, Prato, Italy.
Daniele SantiniOncologia Medica, Università Campus Bio-Medico, vai Alvaro del Portillo 200, 00128, Rome, Italy.
Alfredo FalconeDipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 Universitaria, Azienda Ospedaliero-Universitaria Pisana, Via Roma 67, 56126, Pisa, Italy. alfredo.falcone@med.unipi.it.
all the investigators of the Gruppo Oncologico del Nord Ovest

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChemotherapy 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/

designTRIBE-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 registrationTRIBE2 is registered at Clinicaltrials.gov: NCT02339116 . January 12, 2015. TRIBE-2 is registered at EUDRACT 2014-004436-19, October 10, 2014.

Indexed as

Research DesignAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCamptothecinColorectal NeoplasmsDisease-Free SurvivalFluorouracilHumansLeucovorinNeoplasm MetastasisOrganoplatinum CompoundsProspective StudiesTreatment OutcomeBevacizumabCamptothecinFluorouracilLeucovorinOrganoplatinum CompoundsBevacizumabClinical trialColorectal cancerFolfoxiriStrategy

Identifiers

PMID28599628
PMCPMC5466800

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.