At a glance
ClinicalIndex Comparison Record- ✓Age greater than 18 years
- ✓Histopathological diagnosis of GEP-NET
- ✓Well differentiated G2 (Ki67 ≥3-20%) OR G3 (Ki67 >20-55%) OR Well-differentiated G1 (<3%) with disease progression in last 6 months
- ✓Positive Ga-68-DOTANOC PET/CT with Krennings score ≥3
- ✕Serum creatinine >1.6 mg/dl or creatinine clearance <50 ml/min
- ✕Hemoglobin <8.0 g/dl
- ✕Platelet count <75,000 per cubic millimeter
- ✕Total bilirubin >3 times upper limit of normal
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PReCedeNT Trial: Phase III Randomised Controlled Open Label Trial of Lutetium 177 PRRT Plus Chemotherapy Versus PRRT Aalone in FDG Avid Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors
In Brief
A Phase 3 clinical trial evaluating Peptide Receptor Radionuclide Therapy with Lu177 DOTATATE and Capecitabine plus temozolamide for Neuroendocrine Neoplasia's (NENs) and 2 related conditions. Currently recruiting, targeting 162 participants across 2 sites.
Detailed Summary
Neuroendocrine tumours (NETs), better defined as neoplasms (NENs), are a heterogeneous group of neoplasms that range from well-differentiated tumours to more aggressive carcinomas. Peptide receptor radionuclide therapy (PRRT) with Lutetium-177 DOTATATE is the established standard of care for patients with well-differentiated metastatic or locally advanced GEP-NETs. It has demonstrated a significant improvement in outcomes compared to Octreotide LAR, both as a first-line and second-line treatment approach, following the results of NETTER-1 and NETTER-2 trials, respectively. ENETS guidelines recommend the use of Ga-68 labeled DOTANOC/TOC/TATAE imaging only for WHO Grade 1 NET whereas FDG PET is the preferred modality for WHO Grade 3 NEN and NEC. For Grade 2 tumors (Mib index ranging from 3-20%), there are no strong recommendations for the addition of FDG PETCT in existing diagnostic algorithm. FDG PET positivity has been shown to be an independent predictor of shorter progression-free and overall survival in NET patients undergoing peptide receptor radionuclide therapy (PRRT). (8) Consequently, it is imperative to address FDG-avid tumors by integrating PRRT and chemotherapy. There are no strong recommendations for the grade wise management of GEP-NETs particularly grade 2 \& 3. Although recently published NETTER 2 trial substantiated the role of PRRT as a first line treatment for advanced grade GEP-NETs, still there is lack of evidence supporting the addition of chemotherapy in management of GEP-NETs. Given the absence of a prospective study to establish this treatment regimen, we designed a Phase 3 Randomized Controlled Trial to evaluate the combination of PRRT and CAPE-TEM-based chemotherapy in patients with FDG-positive metastatic well-differentiated NETs.
Study Details
Timeline
Interventions
Radionuclide Therapy
Chemotherapy