Health Condition 1: C269- Malignant neoplasm of ill-definedsites within the digestive system
Conditions
Interventions
Intervention1: Peptide Receptor Radionuclide Therapy plus Chemotherapy: Arm A Peptide Receptor Radionuclide Therapy plus Chemotherapy
Peptide Receptor Radionuclide Therapy with Lu-177-DOTATATE, 180-2
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) is defined as the time duration from the date of randomization to the tumor progression or death from any cause. Patients alive at last follow-up will be censored at the date of last follow-up visitTimepoint: 8 years | — |
Secondary
| Measure | Time frame |
|---|---|
| -Objective Tumor Response -Quality of Life parametersTimepoint: 8 years | — |
Countries
India
Contacts
Public ContactDr Ameya Puranik
Tata Memorial Hospital
Outcome results
None listed