NCT07910760Toborzás még nem indult3. fázis
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 2.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 123 (tervezett)
- Első benyújtás
- 2026. okt. 6.
- Kezdés
- 2026. okt. 11.
- Elsődleges befejezés
- 2031. okt. 11.
- Fő szponzor
- Tata Memorial Hospital
- Betegségek
- Neuroendokrin daganatok
- NCT-szám
- NCT07910760
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 123
- 2026. okt. 11. és az elsődleges befejezés (2031. okt. 11.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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.
Más betegség
- 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
Egyéb
- Pregnant women and breastfeeding women.
- Patient's refusal to give informed consent and participate in the study.
Kiket keres a vizsgálat
- 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)
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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