Gastro-enteropancreatic Neuro-endocrine tumors (GEP-NETs) are rare slow-growing cancers which commonly involve the abdominal organs like liver, stomach, intestines and pancreas. Their incidence has been documented to have increased over the last decade, thus resulting in treatment options being developed to treat these cancers. These cancers spread commonly to the liver, followed by lungs, bones and other sites. Depending on the extent of disease seen on scan, treatment is planned. Patients are advised Peptide Receptor Radionuclide Therapy (PRRT), which is the current standard of treatment for metastatic GEP-NETs. Radio-isotopes labeled to octreotide analogs bind to somatostatin receptors on surface of cancer cells and deliver radiation to the cancer cells when injected into the body. Lu-177 (Lutetium-177) is one such radioisotope which has been used for tagging to the octreotide and is known as Lu-177 DOTATATE PRRT, which is now routinely used in clinical practice. Terbium-161 is another radioisotope which can be labeled to octreotide and used for PRRT. It has advantages over Lu-177 such that it specifically reaches the tumor sites and does not affect the surrounding normal cells, due to its higher penetrating capacity and shorter range of travel. This will benefit patients as the effectiveness of PRRT will be higher with lesser side effects. However, the investigators can only do this by performing a study. Response to treatment can be evaluated by performing scans and side effects, if any can be studied by performing blood tests.
Male or female, age greater than 18 years
Histopathological diagnosis of well-differentiated GEP-NET
Positive Ga-68-DOTANOC PET/CT, Krennings score >/=3
Locally advanced/inoperable disease or metastatic disease
Serum creatinine level of more than 1.6 mg/dl or a creatinine clearance of less than 50 ml/min
Hemoglobin level of less than 8.0 g per deciliter
Red blood cell count less than 300,000/cubic millimeter
White cell count of less than 2000 per cubic millimeter
Single group
Terbium 161
DrugAuger-emitter Peptide Receptor Radionuclide Therapy
Disease control rate
Disease control rate will be measured as a primary endpoint. It is percentage of patients achieving complete or partial response or stable disease on Ga-68 DOTATATE PET/CT. Response assessment will be done using RECIST 1.1 for solid tumors. Non-PD (non-disease progression) after one session of Tb-161 therapy will be eligible for the second session. Patients showing CR with no residual measurable disease will not undergo a second session of therapy. Patients with PD after 1 cycle of Tb-161 DOTATATE therapy will not continue in the study
Quality of Life assessment
Clinical and Quality of Life Assessment using EORTC QLQ C30
Safety Assessment
At each visit, the investigator will evaluate the subject to determine whether any AEs have occurred. CBC, LFT, RFT, Serum electrolytes will be done at 2 weeks, 4 weeks and 6 weeks after each therapy. AEs may be directly observed, reported spontaneously by the subject or by questioning the subject at each study visit. All laboratory values will be evaluated by the Investigator as to clinical significance. All post-baseline abnormal laboratory values considered clinically significant by the Investigator will be recorded as an AE. The NCI Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5.0) will be used to classify and grade the intensity of adverse events during and after each treatment cycle. CTCAE will be used to grade all events regardless of attribution, in order to ensure objective reporting, and in order to report trial data according to accepted international guidelines. The highest grade of each observed toxicity will be recorded.
Quality of Life assessment using QLQ-GI.NET21 questionnaire
Clinical and Quality of Life Assessment using EORTC QLQ-GI.NET21
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