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PRRT Versus PRRT Plus Chemotherapy in GEP NET (PReCedeNT Trial)

RecruitingPhase 3Ages 18 Years - anyAllTata Memorial Hospital
NCT07185672 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 algori

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male or female, age greater than 18 years * Histopathological diagnosis of GEP-NET, necessarily satisfying all the the criteria below * Well differentiated G2 (Ki67 : ≥3-20%) OR G3 (ki67- greater than 20-55%), OR * Well-differentiated G1 (\<3%) with disease progression in last 6 months * Positive Ga-68-DOTANOC PET/CT, Krennings score \>/=3 * Positive FDG PET imaging, grade 3 or 4 uptake * Locally advanced/inoperable disease or metastatic disease * Karnofsky performance-status score of at least 60 or ECOG performance status \</= 2 * Life expectancy greater than 6 months Exclusion Criteria: * 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 noty 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 * Treatment with more than 30 mg of octreotide LAR within 4 weeks before randomisation. * Peptide receptor radionuclide therapy at any time before randomisation * Pregnancy and Lactation * Patients with concurrent malignancies
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What it tests

  • Peptide Receptor Radionuclide Therapy with Lu177 DOTATATE
  • Capecitabine plus temozolamide
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Where

2 sites
Tata Memorial Hospital, Mumbai, India
Mumbai, India
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Navi Mumbai, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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