Status:
RECRUITING
PRRT Versus PRRT Plus Chemotherapy in GEP NET (PReCedeNT Trial)
Lead Sponsor:
Tata Memorial Hospital
Conditions:
Neuroendocrine Neoplasia's (NENs)
Neuroendocrine Tumor GEP Grade 1-3
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ra...
Detailed Description
Neuroendocrine tumors (NETs) are a heterogeneous group of malignancies ranging from well- differentiated, slowly growing tumors to poorly differentiated neoplasms, which are aggressive and less freque...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 7 2027
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT07185672
Start Date
August 7 2019
End Date
August 7 2027
Last Update
September 22 2025
Active Locations (2)
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1
Tata Memorial Hospital, Mumbai, India
Mumbai, Maharashtra, India, 400012
2
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Navi Mumbai, Maharashtra, India, 410210