OncoMatch/Clinical Trials/NCT07185672
PRRT Versus PRRT Plus Chemotherapy in GEP NET (PReCedeNT Trial)
Is NCT07185672 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Capecitabine plus temozolamide for neuroendocrine neoplasia's (nens).
Treatment: Capecitabine plus temozolamide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Performance status
KARNOFSKY/ECOG 60–2
Karnofsky performance-status score of at least 60 or ECOG performance status </= 2
Prior therapy
Cannot have received: peptide receptor radionuclide therapy
Peptide receptor radionuclide therapy at any time before randomisation
Cannot have received: somatostatin analog (octreotide LAR)
Exception: more than 30 mg within 4 weeks before randomisation
Treatment with more than 30 mg of octreotide LAR within 4 weeks before randomisation
Lab requirements
Blood counts
Hemoglobin level of less than 8.0 g per deciliter; Red blood cell count not less than 300,000/cubic millimeter; White cell count of less than 2000 per cubic millimeter; Platelet count of less than 75,000 per cubic millimetre
Kidney function
Serum creatinine level of more than 1.6 mg/dl or a creatinine clearance of less than 50 ml/min
Liver function
Total bilirubin level of more than 3 times the upper limit of the normal range; Serum albumin level < 3.0 g/dl
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 not less than 300,000/cubic millimeter White cell count of less than 2000 per cubic millimeter; Platelet count of less than 75,000 per cubic millimetre; Total bilirubin level of more than 3 times the upper limit of the normal range; Serum albumin level < 3.0 g/dl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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