U.S. NCI issues guidance for deliberations on rare cancer trial closures

  • Date: 12 Jun 2012

On 22 May 2012, the U.S. National Cancer Institute (NCI) Office of Cancer Centres has published the following announcement on the NCI Website

Participation in Trials of Rare Cancers

NCI-designated Cancer Centres play a key national role in developing new therapies in rare cancers. Centres are expected to lead, and/or participate in, NCI’s National Clinical Trials Network trials, including studies of rare cancers.

While Centres, through their Protocol Review and Monitoring System (PRMS), have the authority to close trials for poor accrual, exceptions should be made for trials involving rare diseases. It is not expected that any single Centre will be able to meet minimum annual accrual requirements for rare disease trials. For this reason, these trials need many centres involved to have the greatest potential to meet their accrual targets

NCI staff in the Division of Cancer Treatment and Diagnosis are working with a group of international organizations on an “International Rare Cancers Initiative” (IRCI) and that initiative defines it as a cancer with an incidence of ≤ 3 newly diagnosed persons out of a population of 100,000 persons per year (≤ 3/100,000 per year). Other organizations and conference panels (e.g., ESMO Rare Cancers Conference 2012) have set the incidence rate for a rare cancer slightly higher at ≤6/100,000. Using either definition or cut-off, virtually all paediatric cancer types would be considered “rare cancers.”

As general guidance for PRMS deliberations on trial closures, it seems reasonable to consider as ‘rare cancers’ any cancer types with an incidence rate per 100,000 person population per year in the range of the figures cited above - including all paediatric cancers.

The following international websites may be helpful as additional resources:

—posted 05/22/2012"