NCT07185672 PRRT Versus PRRT Plus Chemotherapy in GEP NET (PReCedeNT Trial)
| NCT ID | NCT07185672 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tata Memorial Hospital |
| Condition | Neuroendocrine Neoplasia's (NENs) |
| Study Type | INTERVENTIONAL |
| Enrollment | 162 participants |
| Start Date | 2019-08-07 |
| Primary Completion | 2027-08-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 162 participants in total. It began in 2019-08-07 with a primary completion date of 2027-08-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Ameya Puranik, MD
PRINCIPAL INVESTIGATOR
Professor and Consultant
Frequently Asked Questions
Who can join the NCT07185672 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuroendocrine Neoplasia's (NENs). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07185672 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 162 participants.
Is NCT07185672 currently recruiting?
Yes, NCT07185672 is actively recruiting participants. Contact the research team at sushilyadav.crc@gmail.com for enrollment information.
Where is the NCT07185672 trial being conducted?
This trial is being conducted at Mumbai, India, Navi Mumbai, India.
Who is sponsoring the NCT07185672 clinical trial?
NCT07185672 is sponsored by Tata Memorial Hospital. The principal investigator is Ameya Puranik, MD at Professor and Consultant. The trial plans to enroll 162 participants.