Health Condition 1: C7A0- Malignant carcinoid tumors
Conditions
Interventions
Intervention1: 177Lu-DOTATATE plus capecitabine: 177Lu â?? DOTATATE approximately 7.4 GBq (200 mCi) per cycle. up to 4 cycles, at 8 weekly intervals
Oral capecitabine 1250 mg/m2 per day from days 0 t
Sponsors
Postgraduate Institute of Medical Education and Research Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: Adults >= 18 years with histopathologically proven, well-differentiated grade 1/2 gastroenteropancreatic neuroendocrine tumours Progressive inoperable/metastatic disease during or after Significant somatostatin receptor (SSTR) expression in 68Ga-DOTANOC PET/CT defined as SUVmax of lesion being significantly (1.5 x) greater than that of normal liver Dedifferentiation excluded using 18F-FDG PET/CT as per the NETPET score ECOG performance 0-2 Estimated life expectancy of at least 8 months Adequate renal function â?? GFR >= 50 mL/min (as estimated by 99mTc DTPA GFR) Stable haematological parameters: Haemoglobin >= 8 g/dL Total leucocyte count >= 2000/mcL Platelets >= 70000/mcL Adequate liver function: Bilirubin AST, ALT, ALP Albumin >= 3.0 g/dL
Exclusion criteria
Exclusion criteria: Patient not willing to give the consent Primary tumours other than gastroenteropancreatic neuroendocrine tumours Grade 3 neuroendocrine tumours Cytotoxic chemotherapy or targeted therapy including somatostatin analogues within the last four weeks Prior Peptide Receptor Radionuclide Therapy Prior Selective Internal Radiation Therapy with 90Y microspheres for liver lesions Any other active malignancy Poorly controlled concurrent medical illness e.g. uncontrolled diabetes, cardiac disease, severe infection Malabsorption syndromes that might impair absorption of Capecitabine Pregnant and lactating female patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, i.e. proportion of patients with complete response plus partial response (as per RECIST 1.1), assessed by 68Ga-DOTANOC PET/CTTimepoint: At around 8 weeks after 2nd cycle and completion of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical response rate i.e proportion of patients achieving â?¥50% reduction in serum chromogranin A levelTimepoint: At around 8 weeks after 2nd cycle and completion of treatment;Disease Control RateTimepoint: At around 8 weeks after 2nd cycle and completion of treatment;Health related quality of life assessed using EORTC QLQ â?? C30 questionnaireTimepoint: At around 8 weeks after 2nd cycle and completion of treatment;Progression free survivalTimepoint: Estimated from the first PRRT cycle till documented radiological disease progression (as per RECIST 1.1). Patients will be followed up for a minimum of 2 years;Proportion of serious adverse events, assessed using CTCAE version 5.0Timepoint: Every 3 weeks post each treatment cycle | — |
Countries
India
Contacts
Public ContactAshwani Sood
PGIMER
Outcome results
None listed