utetium DOTATATE plus capecitabine in advanced neuroendocrine tumours

Phase 2

Conditions: Health Condition 1: C7A0- Malignant carcinoid tumors

Registration Number: CTRI/2020/01/022636

Lead Sponsor: Postgraduate Institute of Medical Education and Research Chandigarh

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Adults >= 18 years with histopathologically proven, well-differentiated grade 1/2 gastroenteropancreatic neuroendocrine tumours

Progressive inoperable/metastatic disease during or after <= 2 prior systemic therapies

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 <= 3 x upper limit of normal (ULN)

AST, ALT, ALP <= 2.5 x ULN (or <= 5.0 x ULN in the presence of liver metastases)

Albumin >= 3.0 g/dL

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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