OncoMatch/Clinical Trials/NCT01876771
A Trial to Assess the Safety and Effectiveness of Lutetium-177 Octreotate Therapy in Neuroendocrine Tumours
Is NCT01876771 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies [177]Lu-DOTA-TATE for carcinoma, neuroendocrine.
Treatment: [177]Lu-DOTA-TATE — Neuroendocrine tumours (NETs) are rare, slow growing, and diagnosis is often delayed with advanced metastases at presentation. In select patient populations, radioisotope therapy with Lutetium-177 (Lu-DOTA-TATE) has been shown to be a safe and effective palliative therapy, and has been widely used by research groups in Europe. A brand of Lu-DOTA-TATE (Lutathera(R)) is approved for the treatment of gastroenteropancreatic NETs in Europe, the U.S., and more recently in Canada. While Lutathera(R) is approved in Canada, it is not publicly funded in Alberta. Lu-DOTA-TATE has been used at the Cross Cancer Institute to treat more than 300 patients with NETs since August, 2010. Our Lu-DOTA-TATE treatment was initially given under Health Canada's Special Access Programme (SAP), with each individual treatment requiring separate approval. In 2014, Health Canada requested we conduct a clinical trial with Lu-DOTA-TATE instead. The purpose of this study is to: 1) assess the efficacy of Lu-DOTA-TATE treatment in patients with somatostatin receptor positive tumours; 2) assess the safety of Lu-DOTA-TATE; 3) assess the effect of Lu-DOTA-TATE on Quality of Life and survival.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: Lutetium-177 DOTA-TATE — prior therapy (Group B only)
Have previously received Lu-DOTA-TATE treatment under the SAP.
Cannot have received: Lutetium-177 DOTA-TATE
Have previously received Lu-DOTA-TATE therapy.
Cannot have received: liver embolization (TAE, TACE, TARE)
Liver embolization [transcatheter arterial embolization (TAE), TACE, or TARE] within 4 weeks of enrolment.
Cannot have received: radioisotope therapy
Radioisotope therapy within 12 weeks of enrolment.
Cannot have received: mTOR inhibitor
mTOR inhibitors within 6 weeks of enrolment.
Cannot have received: tyrosine kinase inhibitor
tyrosine kinase inhibitors within 6 weeks of enrolment.
Cannot have received: chemotherapy
chemotherapy within 8 weeks of enrolment.
Cannot have received: interferon
interferon within 8 weeks of enrolment.
Cannot have received: external beam irradiation
Exception: permitted if target lesion(s) not in the radiation field
Localized external beam irradiation with target lesion(s) in the radiation field. Other localized external beam therapy is permitted.
Cannot have received: radiation therapy to >25% of bone marrow
Prior radiation therapy to more than 25% of the bone marrow.
Lab requirements
Blood counts
Haemoglobin concentration ≥ 90 g/L; WBC count ≥ 2 x 10^9/L; platelets ≥ 100 x 10^9/L measured within 2 weeks of enrolment.
Kidney function
Serum creatinine ≤ 150 μmol/L, and a calculated (Cockcroft-Gault) or estimated GFR of ≥ 50 mL/min measured within 2 weeks of enrollment.
Liver function
Liver function tests (total bilirubin, ALT, AST) ≤ 3X the limit of normal; serum albumin ≥ 23 g/L within 2 weeks of enrolment.
Serum creatinine ≤ 150 μmol/L, and a calculated (Cockcroft-Gault) or estimated GFR of ≥ 50 mL/min measured within 2 weeks of enrollment. Haemoglobin concentration ≥ 90 g/L; white blood cell (WBC) count ≥ 2 x 10^9/L; platelets ≥ 100 x 10^9/L measured within 2 weeks of enrolment. Liver function tests (total bilirubin, alanine transaminase (ALT), aspartate transaminase (AST)) ≤ 3X the limit of normal measured within 2 weeks of enrolment. Serum albumin ≥ 23 g/L within 2 weeks of enrolment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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