International Rare Cancers Initiative

Rare cancers: Challenges & issues

“…A study of rare tumours in the US used the definition of <15 incident cases per 100,000 annually, roughly corresponding in the US to 40,000 new cases annually or fewer4. To support the progress of international comprehensive clinical trials for those diagnosed with rare tumours, IRCI has generally defined rare cancers as a prevalence of <2/100,00010.…”

“…International clinical trials in rare cancers are possible with appropriate funding, planning and support to develop treatment strategies. In an attempt to address this issue and encourage the development of international trials for rare cancers, the IRCI was established early in 201110. IRCI is a joint initiative by the National Institute for Health Research Cancer Research Network (NCRN), Cancer Research UK (CR-UK), the National Cancer Institute (NCI) and the European Organization for Research and Treatment of Cancer (EORTC).…”

“…IRCI brings together international professionals and experts in rare cancers and associated groups that have the competence to carry out clinical trials across national boundaries. It also provides an environment for associate groups to prioritize global rare cancer policies, organize discussion of clinical trials in cancers that otherwise lack international organizing infrastructure, aid evaluation of ideas and procedures by associate groups, work to lower barriers to performance of international clinical trials in cancer and offer a public support for clinicians with academic interest to approach industry for international cooperation in rare cancer clinical trials10. So far, IRCI has exempted rare molecular subtypes of frequent cancers; however, a rare molecular subtype can 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.…”

“…Europe has initiated efforts89, and it is hoped that other countries, particularly developing countries such as India and other resource-limited countries, will see the importance and potential benefit of studies on rare cancers. The International Rare Cancers Initiative (IRCI) has selected nine rare cancers in adults that include anaplastic thyroid cancer, small bowel adenocarcinoma, fibrolamellar hepatocellular carcinoma, gynaecological sarcoma, salivary gland cancer, thymoma, penile cancer, relapsed/metastatic anal cancer and ocular melanoma10. The selection of these cancers by IRCI was based not only on the rarity of the disease but also ensuring that there were no existing randomized controlled trials and international trial group for these diseases.…”

The National Clinical Trials Network: Conducting Successful Clinical Trials of New Therapies for Rare Cancers

“…4 However, this metric poorly reflects the public health burden of cancer, an incident disease. 5 At a 2007 workshop sponsored by the National Cancer Institute's Epidemiology and Genetics Research Program and the National Institute of Health's Office of Rare Diseases, rare cancers were defined as those cancers for which the incidence rate is less than 15 cases per 100,000 population or fewer than 40,000 new cases per year in the United States. 6 Although these numbers are relatively small, all rare cancers combined account for 27% of cancers diagnosed each year and 25% of cancer-related deaths in the United States.…”