Australasian Gastrointestinal Trials Group (AGITG) CONTROL NET Study: Phase II Studies of Lu-Octreotate Peptide Receptor Radionuclide Therapy (LuTate PRRT) +/- Capecitabine, Temozolomide (CAPTEM) or CAPTEM Alone for Neuroendocrine Tumours (NETs
Introduction: Chemotherapy is often combined with PRTT to treat NETs of pancreatic or midgut origin (pNET/mNET) based on the principle of radiosensitization.
Aim(s): To determine the relative activity of CAPTEM/PRRT in G1-2, unresectable, metastatic mNET and pNET.
Materials and methods: mNET: Phase II 2:1 randomisation PRRT /CAPTEM vs. PRRT (control); pNET: 2:1 randomisation to PRRT /CAPTEM vs CAPTEM (control). PRRT /CAPTEM: 7.8GBq LuTate day(D) 10, 8 weekly (wkly) x 4, with b.i.d. oral CAP 750mg/m2 D1-14 & TEM 75mg/m2D10-14, 8 wkly x 4, vs. PRRT 8 wkly x 4, or CAPTEM 4wkly x 8. Primary endpoint: Progression free survival (PFS) (15 months (m) mNETs/12m pNETs). Secondary endpoints: objective tumour response rate (OTRR), clinical benefit rate (CBR), toxicity, QOL.
Conference: 17th Annual ENETSConcerence (2020)
Presenting Author: Pavlakis N
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