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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Oral capecitabine 750 mg/m2 twice a day, Day 1 to 14 and oral temozolomide 200 mg/m2 once a day, Day 10 to 14
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
Response rate
Proportion of patients with complete or partial response graded by Response Evaluation Criteria in Solid Tumors version 1.1
Time frame: 2 years
Progression-free survival
Time between the start of study treatment and disease progression
Time frame: 2 years
Overall survival
Time between the start of study treatment and survival
Time frame: 2 years
Toxicity (Adverse events graded by National Cancer Institute-Common Terminology Criteria version 4.03)
Adverse events graded by National Cancer Institute-Common Terminology Criteria version 4.03
Time frame: 2 years
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