Unresectable or reccurent gastroenteropancreatic neuroendocrine tumor.
Conditions
Interventions
Arm A : Daily oral administration of everolimus (10mg/body), until meeting the termination criteria for protocol treatment.
Arm B : Daily oral administration of everolimus (10mg/body) and deep subcuta
Sponsors
MIZUNO Nobumasa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically proven well-differentiated neuroendocrine tumor. (2) HE-stained section and immunostained sections for Chromogranin A, Synaptophysin, and Ki-67 of the biopsy specimen, used for diagnosis in (1) is available for central pathological review. (3) Primary tumor is located in the pancreas, duodenum (excluding the ampulla of Vater), jejunum, ileum, stomach, colon, or rectum. (4) Unresectable primary tumor or unresectable recurrent tumor. In cases of recurrent tumors diagnosed in imaging studies, histologic reconfirmation of the recurrent location or the primary location in not mandatory if the diagnosis of the primary location is confirmed in the past. (5) Non-functional neuroendocrine tumor. (6) Satisfies either (i) or (ii). (i) Ki-67 LI >= 5% and Ki-67 LI = 1,200/mm3 (ii) Hemoglobin >= 8.0 g/dL(transfusion within 14 days before the blood test is not permissible) (iii) Platelet count >= 75000 /mm3 (iv) Total bilirubin <= 2.0 mg/dL (v) AST <= 100 U/L(<= 200 U/L if liver metastasis present) (vi) ALT <= 100 U/L(<= 200 U/L if liver metastasis present) (vii) Creatinine <= 1.5 mg/dL (viii) Casual blood glucose <= 200 mg/dL (14) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) History of synchronous or metachronous (within 2 years) malignancies with 5-year relative survivals of less than 95% at the time of diagnosis.) (2) Active infection requiring systemic therapy other than viral hepatitis. (3) Fever of higher than 38.0 degrees celsius at the time of enrollment. (4) Pregnant, possibly pregnant, within 28 days after delivery, breastfeeding female or males expecting conception of their child. (5) Psychiatric illnesses or symptoms affecting daily lives. (6) Systemic administration of steroids or immunosuppressive agents. (7) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT. (8) Severe complications such as heart failure, renal failure, liver failure, hemorrhagic gastric ulcer, intestinal paralysis, or bowel obstruction. (9) Unstable angina (diagnosis or worsening of chest pain within 6 weeks) or history of myocardial infarction within 6 months prior to enrollment. (10) Uncontrollable diabetes (HbA1c > 8%). (11) Positive for HIV antibodies. (12) Administration of live attenuated vaccines within 7 days of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (key secondary), response rate, disease control rate, adverse event rate. | — |
Contacts
Public ContactNobumasa MIZUNO
Aichi Cancer Center Hospital
Outcome results
None listed