Capecitabine ON Temozolomide Radionuclide Therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study

Phase 2 Completed 75 enrolled Australasian Gastro-Intestinal Trials Group

RandomizedParallel-groupOpen-labelTreatment

Summary

Two parallel phase II randomized open label trials of Lutetium-177 Octreotate (177Lu-Octreotate) peptide receptor radionuclide therapy (PRRT) and capecitabine (CAP)/temozolomide (TEM) chemotherapy (chemo): (i) versus CAPTEM alone in the treatment of low to intermediate grade pancreatic neuroendocrine tumours (pNETs); (ii) versus PRRT alone in the treatment of low to intermediate grade mid gut neuroendocrine tumours (mNETs).

Timeline

Start: 2015-11
Primary completion: 2021-10-31
Completion: 2021-10-31

Publications

Chan DL, Sjoquist KM, Ransom DT, Wyld D, Wilson K, Gebski V, Murray J, Kiberu AD, Burge ME, Macdonald W, Roach P, Pattison DA, Butler P, Price TJ, Michael M, Lawrence BJ, Bailey DL, Leyden J, Leyden S, Zalcberg JR, Turner JH, Pavlakis N. [177Lu]Lu-DOTATATE PRRT and CAPTEM chemotherapy for pancreas and small bowel neuroendocrine tumours: The AGITG CONTROL NETS Multi-centre randomized trial. Eur J Cancer. 2026 Jun 18;241:116781. doi: 10.1016/j.ejca.2026.116781. Epub 2026 May 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	750 mg/m2	Oral
Subject	Temozolomide	Small molecule	75 mg/m2	Oral
Subject	octreotate	Peptide	7800 mbq	Intravenous

Capecitabine ON Temozolomide Radionuclide Therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study

Summary

Timeline

Publications

Drugs

Indications