The study aims at comparing the efficacy of radio-isotope therapy (Lutetium-177 PRRT) alone and combination therapyof radio-isotope and chemotherapy in neuroendocrine tumors which show somatostatin and glucose receptor expression.
- Conditions
- Health Condition 1: C269- Malignant neoplasm of ill-definedsites within the digestive system
- Registration Number
- CTRI/2019/07/020388
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Histopathological diagnosis of GEP-NET
necessarily satisfying all the the criteria
below
2. Well differentiated G2 Ki67 more than 5-20%
and G3 ki67- greater than 20-55%
3. Well-differentiated G1 and G2 2 to5% with
disease progression in last 6 months
4. Positive Ga68 DOTANOC PETCT - Krennings
score more than equal to 3
5. Positive FDG PET imaging, grade 3 or 4 uptake
6.Locally advanced or inoperable disease or
metastatic disease
7. Karnofsky performance-status score of at
least 60 or ECOG performance status less
than or equal to 2
8. Life expectancy greater than 6 months
1. Serum creatinine level of more than 1.6 mg
per dl or a creatinine clearance of less
than 50 ml per min
2. Hemoglobin level of less than 8.0 g per
deciliter
3. Red blood cell count not less than
300,000 per cubic millimeter
4. White cell count of less than 2000 per cubic
millimeter
5. Platelet count of less than 75,000 per cubic
millimetre
6. Total bilirubin level of more than 3 times
the upper limit of the normal range
7. Serum albumin level more than 3.0 g per dl
8. Treatment with more than 30 mg of octreotide
LAR within 12 weeks before randomisation
9. Peptide receptor radionuclide therapy at any
time before randomisation
10.Pregnancy and Lactation
11.Patients with concurrent malignancies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method