EORTC Clinical Trial in PerspectiveA multinational, multi-tumour basket study in very rare cancer types: The European Organization for Research and Treatment of Cancer phase II 90101 ‘CREATE’ trial
Section snippets
Conflict of interest statement
P.S. has received a single institutional travel grant from Pfizer for presentation of results of this trial in the recent past. The other authors have no actual or potential conflict of interest to disclose in relation with this work.
Acknowledgement
The authors are grateful to Pfizer for supporting this study through an educational grant. The work of J.P. as Fellow at EORTC Headquarters was supported by a grant from Fonds Cancer (FOCA) from Belgium.
References (16)
- et al.
Crizotinib in patients with advanced, inoperable inflammatory myofibroblastic tumours with and without anaplastic lymphoma kinase gene alterations (European Organisation for Research and Treatment of Cancer 90101 CREATE): a multicentre, single-drug, prospective, non-randomised phase 2 trial
Lancet Respir Med
(2018) - et al.
The tyrosine kinase inhibitor crizotinib does not have clinically meaningful activity in heavily pre-treated patients with advanced alveolar rhabdomyosarcoma with FOXO rearrangement: european Organisation for Research and Treatment of Cancer phase 2 trial 90101 “CREATE”
Eur J Cancer
(2018) - et al.
Activity and safety of crizotinib in patients with alveolar soft part sarcoma with rearrangement of TFE3: european Organization for Research and Treatment of Cancer (EORTC) phase II trial 90101 “CREATE”
Ann Oncol
(2018) - et al.
Activity and safety of crizotinib in patients with advanced clear-cell sarcoma with MET alterations: european Organization for Research and Treatment of Cancer phase II trial 90101 “CREATE”
Ann Oncol
(2017) - et al.
Crizotinib achieves long-lasting disease control in advanced papillary renal-cell carcinoma type 1 patients with MET mutations or amplification. EORTC 90101 CREATE trial
Eur J Cancer
(2017) Optimal two-stage designs for phase II clinical trials
Contr Clin Trials
(1989)- et al.
Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas
Eur J Cancer
(2002) - et al.
Vemurafenib in multiple nonmelanoma cancers with BRAF V600 mutations
N Engl J Med
(2015)
Cited by (18)
Biology-guided precision medicine in rare cancers: Lessons from sarcomas and neuroendocrine tumours
2022, Seminars in Cancer BiologyCitation Excerpt :Furthermore, biologically defined subgroups exist even in rare cancers, like in common malignancies. The resulting small patient numbers complicate the design and execution of clinical trials and the attraction of interest from pharmaceutical companies – a challenge increasingly addressed in recent years by cross-institutional, sometimes nationwide, collaboration and histology-independent basket trials [5–9]. To highlight different clinical implications of the biological understanding of rare cancers, we will first discuss sarcomas as an example of tumours with heterogeneous molecular aberrations that have important consequences for diagnosis and classification as well as personalised pharmacologic treatment options.
‘Rare cancers’: not all together in clinical studies!
2022, Annals of OncologyCombination of HGF/MET-targeting agents and other therapeutic strategies in cancer
2021, Critical Reviews in Oncology/HematologyBasket trials: From tumour gnostic to tumour agnostic drug development
2020, Cancer Treatment ReviewsCitation Excerpt :BTs testing larotrectinib and entrectinib are very recent examples for such a direct impact [59,60]. Cunanan et al [61] discern three different types of BTs: i) one drug – one oncokinase – multiple diseases (such as the vemurafenib-BT [62]); ii) one drug – multiple oncokinases – multiple diseases (such as the CREATE trial [63]); iii) multiple drugs – multiple oncokinases – multiple diseases (such as the CUSTOM trial [64]). BTs are considered as a series of independent phase 2 trials by several trialists.
The Evolution of Master Protocol Clinical Trial Designs: A Systematic Literature Review
2020, Clinical TherapeuticsInflammatory myofibroblastic tumor: The experience of the European pediatric Soft Tissue Sarcoma Study Group (EpSSG)
2020, European Journal of CancerCitation Excerpt :For the pediatric age group, it is important to mention the Children’s Oncology Group (COG) phase I/II trial on crizotinib, which reported 5 complete and 7 partial responses among 14 patients aged 2–13 years (an 86% response rate) [15]. As for adult cohorts, important data emerged from the CREATE study, a multinational multitumor phase II basket trial developed by the European Organisation for Research and Treatment of Cancer (EORTC) [16,21]. The CREATE study was designed to examine the efficacy and safety of crizotinib in six parallel cohorts of patients.