Health Condition 1: C7A0- Malignant carcinoid tumors
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Histopathological diagnosis of well differentiated GEP NET Positive Ga-68-DOTANOC PET CT with Krennings score greater than or equal to 3 Locally advanced or inoperable disease or metastatic disease Patient who have shown disease progression with Lu177 DOTATATE PRRT Karnofsky performance status score of at least 60 or ECOG performance status greater than or equal to 2 Life expectancy greater than 6 months
Exclusion criteria
Exclusion criteria: Serum creatinine level of more than 1.6 mg per deciliter or a creatinine clearance of less than 50 ml per min Hemoglobin level of less than 8.0 g per deciliter Red blood cell count less than 300,000 per cubic millimeter White cell count of less than 2000 per cubic millimeter Platelet count of less than 75,000 per cubic millimetre Total bilirubin level of more than 3 times the upper limit of the normal range Serum albumin level greater than 3.0 g/dl Pregnancy and Lactation Patients with concurrent malignancies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rateTimepoint: 4 to 6 weeks after each cycle of Terbium 161 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety using CTCAE 5.0Timepoint: every 4 weeks | — |
Countries
India
Contacts
Tata Memorial Hospital, Mumbai