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TRINITY TRIAL; Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETS
Sponsor: Tata Memorial Hospital
Summary
The goal of this Phase III randomized controlled, open-label clinical trial is to evaluate the efficacy and safety of adding peptide receptor radionuclide therapy (PRRT) with Lutetium-177 DOTATATE to standard-of-care chemotherapy (CAPTEM), compared with CAPTEM alone, in adults with unresectable or metastatic, WHO Grade 3 well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with a Ki-67 index of \>20% to \<55% and positive somatostatin receptor imaging. The main questions it aims to answer are: * Whether the addition of PRRT to CAPTEM improves 1-year progression-free survival (PFS) compared with CAPTEM alone. * Whether the addition of PRRT to CAPTEM results in differences in \*\*disease control rate, overall survival, treatment-related toxicity, and quality of life\*\* compared with CAPTEM alone. Researchers will compare Arm A (CAPTEM alone) with Arm B (PRRT plus CAPTEM) to evaluate differences in progression-free survival, disease control, overall survival, toxicity, and quality of life between the two treatment groups. Participants will be randomly assigned in a 1:1 ratio to either treatment arm. Participants will: * Undergo screening and baseline assessments, including physical examination, blood investigations, cardiac assessment, and imaging with Ga-68 DOTA PET/CT and FDG PET/CT. * Receive CAPTEM (capecitabine and temozolomide) as oral chemotherapy according to the study protocol. * If assigned to Arm B, receive four sessions of Lutetium-177 DOTATATE PRRT, at intervals of approximately 6-8 weeks, in addition to CAPTEM. * Undergo regular clinical assessments, laboratory investigations, imaging assessments, and monitoring for adverse events and treatment-related toxicity. * Complete EORTC QLQ-C30 and QLQ-GINET21 questionnaires to assess quality of life. * Continue follow-up after treatment, including clinical and imaging assessments, until disease progression or death.
Official title: Phase III Randomized Controlled Open Label Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETS
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
123
Start Date
2026-10-11
Completion Date
2031-10-11
Last Updated
2026-11-02
Healthy Volunteers
No
Interventions
Capecitabine
Oral capecitabine 1500 mg/m² twice daily within 15 minutes of food on Days 1-14, followed by a 2-week rest, for up to 12 cycles. 500 mg tablets.
Temozolomide (TMZ)
Oral temozolomide 20 mg/m² once daily at bedtime on Days 10-14 of each capecitabine cycle, taken on an empty stomach, for up to 12 cycles.
Lutetium Lu 177 Dotatate
180-200 mCi diluted in 100 mL normal saline, given intravenously over 30 minutes with a co-infusion of 10% amino acids (Aminoven 1000 mL) for kidney protection. Given every 6-8 weeks for 4 sessions; up to 8 sessions in patients with a partial response.