Lu-DOTATATE for Neuroendocrine Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing a targeted radiation therapy called Lutetium-177 Octreotate in patients with advanced neuroendocrine tumors that have specific receptors. The treatment aims to deliver radiation directly to the cancer cells to stop their growth. Patients will receive multiple treatment cycles, and their progress will be monitored over time. Lutetium-177 Octreotate was approved by the FDA in January 2018 for treating certain types of neuroendocrine tumors.

Eligibility Criteria

This trial is for adults over 18 with biopsy-proven neuroendocrine tumors, showing progression and positive for Somatostatin receptors. They should have an ECOG performance status ≤ 2, adequate organ function, no prior radionuclide therapy or certain other treatments within the last few weeks, and not be pregnant or breastfeeding.

Inclusion Criteria

Signed informed consent

Ki-67 index ≤ 30%

My case has been reviewed by a tumor board for clinical trial suitability.

+12 more

Exclusion Criteria

I am eligible for a potentially curative surgery or targeted liver therapy.

I am eligible for surgery to remove or reduce my cancer.

I haven't had radiation on the cancer we're targeting in the last 3 months.

+10 more

Participant Groups

The study tests Lutetium-177 Octreotate's effectiveness in patients with neuroendocrine tumors who are Somatostatin receptor-positive. It involves four treatment cycles with possible dose adjustments based on individual responses and will compare progression-free survival at one year.

1Treatment groups

Experimental Treatment

Group I: Lutetium-177 OctreotateExperimental Treatment1 Intervention

Lutetium-177 Octreotate 200 mCi (7.4 GBq) by IV for 18-30 weeks

Lutetium-177 Octreotate is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Lutathera for:

Unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults

🇺🇸 Approved in United States as Lutathera for:

Somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults

🇨🇦 Approved in Canada as Lutathera for: