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BackgroundThe past three decades have seen rapid improvements in the diagnosis and treatment of most cancers and the most important contributor has been research. Progress in rare cancers has been slower, not least because of the challenges of undertaking research.SettingsThe International Rare Cancers Initiative (IRCI) is a partnership which aims to stimulate and facilitate the development of international clinical trials for patients with rare cancers. It is focused on interventional – usually randomised – clinical trials with the clear goal of improving outcomes for patients. The key challenges are organisational and methodological. A multi-disciplinary workshop to review the methods used in ICRI portfolio trials was held in Amsterdam in September 2013. Other as-yet unrealised methods were also discussed.ResultsThe IRCI trials are each presented to exemplify possible approaches to designing credible trials in rare cancers. Researchers may consider these for use in future trials and understand the choices made for each design.InterpretationTrials can be designed using a wide array of possibilities. There is no ‘one size fits all’ solution. In order to make progress in the rare diseases, decisions to change practice will have to be based on less direct evidence from clinical trials than in more common diseases.

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Age and body mass index (BMI) have been shown to correlate with an increased incidence of failure in identifying a sentinel lymph node (SLN). Mapping senior, overweight adults is common; therefore, the relationship of patient age and BMI on SLN biopsy success is essential. This study examines the mapping failures as they relate to age and BMI. From April 1994 to May 1999, patients underwent an injection of radiocolloid (450 mci) and blue dye (5 cc) prior to SLN biopsy. SLN biopsy failure was defined as lymph nodes being unidentifiable by blue dye or having an in vivo node radiocolloid count of less than 3:1 over background count. BMI was measured as (weight in pounds)(703)/(height in inches)(2); 1,356 patients were attempted for SLN mapping, and 54 failed (3.98%). The radioactive node count was inversely proportional to age ( p < 0.0001). The radioactive node count decreased by a mean of 34 counts per node with each additional year ( p < 0.001). The estimated odds ratios for success were 0.945 for age and 0.946 for BMI. Therefore, every increase of 1 year of age or one unit of BMI decreased the odds of success by approximately 5%. The mean BMI was 29.54 in failed patients and was 26.42 in successful mapping patients ( p = 0.042). Surgeons should be aware that node counts will decrease with increasing age and that increased age and BMI are potential risk factors for SLN mapping failure. However, increased age and/or BMI alone do not appear to be contraindications for SLN biopsy in older or overweight patients.