NCT07910760Not yet recruitingPhase 3
TRINITY TRIAL; Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETS
Phase III Randomized Controlled Open Label Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETS
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 123 (estimated)
- First submitted
- 6 Oct 2026
- Start date
- 11 Oct 2026
- Primary completion date
- 11 Oct 2031
- Lead sponsor
- Tata Memorial Hospital
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT07910760
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 123
- From 11 Oct 2026 to the primary completion date, 11 Oct 2031
- No sites listed in no 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
- Participants who are receiving any other investigational agents.
- Patients who have received any cancer-directed therapy within 3 weeks of screening for this study. Patients who have received long-acting somatostatin analogue within or less than 3 weeks prior to the first session of PRRT.
- Prior radiopharmaceutical therapy
- Acute coronary syndrome or acute myocardial infarction ≤ 6 months prior to administration of study intervention.
- Non-study-related minor surgical procedure ≤ 5 days, or major surgical procedure ≤ 21 days, prior to the administration of study intervention; in all cases, the participant must be sufficiently recovered and stable before treatment administration.
Other illness
- Past history of second malignancy
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
- Uncontrolled intercurrent illness including or psychiatric illness/social situations that would limit compliance with study requirements.
- Clinically significant and/or uncontrolled cardiac disease such as congestive heart failure requiring treatment (New York Heart Association \> Class 2), uncontrolled hypertension, clinically significant arrhythmia.
- Active HIV/HBV infections
Other
- Pregnant women and breastfeeding women.
- Patient's refusal to give informed consent and participate in the study.
Who the study is looking for
- HPR proven WHO Grade 3 WD GEP- NETs with Mib index \> 20% to \< 55%
- Positive SSTR imaging (kennings score 3 \& 4) \& FDG PET/CT (uptake more than or equal to liver) done maximum 3-6 weeks prior to randomization, with patients having unresectable/metastatic disease.
- Age more than 18
- ECOG 0 \& 1 or KPS \>/= 70
- Optimal hematological function (Hb\>8, PLT \> 80000, ANC \>1500)
- Optimal renal function (RFT) (eGFR\> 60ml/min)
- Optimal liver function (LFT) (Total bilirubin \< 1.5 × upper limit of normal. AST/ALT≤2.5 × upper limit of normal) Serum Albumin \> 30 g/L (3 g/dl)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.