Abstract
International Rare Cancers Initiative (IRCI).
Highlights
The objective of this initiative is to facilitate the development of international clinical trials for patients with rare cancers in order to boost the progress of new treatments for these patients
The initiative hopes to encourage the use of innovative methodologies, such as Multi-Arm Multi-Stage (MAMS) trial designs and Bayesian statistics, to maximise the potential for answering research questions and to identify and overcome barriers to international trials to allow agreed International Rare Cancers Initiative (IRCI) trials to run smoothly
The IRCI Gynaecological Sarcoma Group has made great progress and in September 2012 the first IRCI study opened to recruitment - A phase III randomised trial of gemcitabine plus docetaxel followed by doxorubicin versus observation for uterus-limited, high grade uterine leiomyosarcoma (IRCI 001, ClinicalTrials.gov registration number NCT01533207)
Summary
The objective of this initiative is to facilitate the development of international clinical trials for patients with rare cancers in order to boost the progress of new treatments for these patients. IRCI has excluded rare molecular sub-types of common cancers; a rare molecular sub-type could be considered if it is a distinct, prospectively identifiable rare sub-group with a strong rationale for separate research, rather than inclusion as a molecular stratum in a mainline trial.
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