NCT07185672RecruitingPhase 3
PRRT Versus PRRT Plus Chemotherapy in GEP NET (PReCedeNT Trial)
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
Source: ClinicalTrials.gov · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 162 (estimated)
- First submitted
- 25 Aug 2025
- Start date
- Aug 2019
- Primary completion date
- Aug 2027
- Lead sponsor
- Tata Memorial Hospital
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT07185672
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 162
- From Aug 2019 to the primary completion date, Aug 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with more than 30 mg of octreotide LAR within 4 weeks before randomisation.
- Peptide receptor radionuclide therapy at any time before randomisation
- Patients with concurrent malignancies
Lab values
- 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
Other
- Pregnancy and Lactation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tata Memorial Hospital, Mumbai, India Coordinator of this site? Confirm its status | Mumbai | India | Recruiting |
| Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Coordinator of this site? Confirm its status | Navi Mumbai | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.