PRRT Versus PRRT Plus Chemotherapy in GEP NET (PReCedeNT Trial)
Recruiting now · Phase 3
Conditions studied: Neuroendocrine Neoplasia's (NENs), Neuroendocrine Tumor GEP Grade 1-3, Neuroendocrine Gastroenteropancreatic Tumour
In brief
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.
Key facts
- Study ID
- NCT07185672
- Run by
- Tata Memorial Hospital
- People needed
- 162
- Starts
- 2019-08-07
- Expected to finish
- 2027-08-07
- Last updated by the study team
- 2025-09-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Tata Memorial Hospital, Mumbai, India — Mumbai, Maharashtra, India (enrolling)
- Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) — Navi Mumbai, Maharashtra, India (enrolling)
Full record on ClinicalTrials.gov
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