TEMCAP in Grade 3 and Low Ki-67 Gastroenteropancreatic Neuroendocrine Tumors
Status:
Active, not recruiting
Trial end date:
2021-10-15
Target enrollment:
Participant gender:
Summary
GI tract including pancreas is the one of most common primary sites of neuroendocrine tumors.
Current grading of neuroendocrine tumors are based on the 2010 WHO classification. This
classifies grade 3 tumors as the neuroendocrine tumor with mitosis > 20 per 10 high power
field or Ki-67 labeling index > 20%. Etoposide-based chemotherapy, mostly as the combination
with cisplatin, has been the mainstay of the treatment for patients with grade 3
neuroendocrine tumors. However, a recent large retrospective analysis has suggested this
regimen may not be effective in relatively low Ki-67 labeling index. Therefore, the
investigators designed a clinical trial testing temozolomide-capecitabine combination, which
has been mostly investigated in well differentiated (ie., grade 1 or 2) neuroendocrine
tumors, in patients with grade 3 and low Ki-67 gastroenteropancreatic neuroendocrine tumors.