OncoMatch/Clinical Trials/NCT07185672
PRRT Versus PRRT Plus Chemotherapy in GEP NET (PReCedeNT Trial)
Is NCT07185672 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
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.
Frequently asked questions
Is NCT07185672 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior peptide receptor radionuclide therapy, somatostatin analog disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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