Recruitment strategy revised for NABNEC

Trial update: NABNEC

The NABNEC trial is almost halfway to its accrual target, with 31 participants at the end of May. NABNEC is a randomised phase II trial of patients with grade 3 neuroendocrine carcinomas (NECs). It aims to determine the safety and efficacy of carboplatin plus nab-paclitaxel in comparison with carboplatin plus etoposide.

One of the main challenges for the study is identifying and recruiting participants, as the trial addresses a disease that is dire, yet rare. “One of the biggest challenges is to think of the study when seeing patients with NECs,” says Principal Investigator Mustafa Khasraw. “We’ve had patients who were seen at sites where the study was open and it wasn’t mentioned to them, not because investigators don’t think it’s important, but because it’s a rare subset of an uncommon cancer, and often the patient is too sick… they think they should start immediately on standard chemotherapy outside the clinical trial.”

The rate of recruitment for the trial is typical of clinical trials for rare cancers. “There is another chemotherapy study in high-grade neuroendocrine cancers in the States, and they have the same problem of slow accrual,” says Dr. Khasraw. “We have to work hard to generate the answers in rare cancers.” In order to make the study as accessible as possible, protocol changes and amendments have been made to NABNEC, with inclusion criteria being adapted to maximise inclusiveness for patients with NECs.

NABNEC is also exploring translational biologic, molecular and functional imaging endpoints to inform future research. “There are translational research projects associated with the study and some of it looks really exciting,” says Dr. Khasraw. “There will be a lot of hypothesis-generating research coming out of it, so it’s important that the study is supported to get the most out of it.”

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