Randomized Phase II Trial of Everolimus 5 mg vs 10 mg Daily for Patients With Advanced Neuroendocrine Tumors

What this Trial Is About

Researchers are evaluating the use of everolimus at two different doses, 5 mg and 10 mg daily, for patients with advanced or metastatic well-differentiated neuroendocrine tumors (NET) that have progressed despite prior treatment. The study is a randomized, open-label phase II clinical trial focused on comparing the effectiveness and safety of these two dosing regimens in patients with Grade 1 or Grade 2 metastatic NET. This research is motivated by concerns about severe side effects associated with the higher 10 mg dose and prior evidence suggesting that 5 mg may effectively block tumor growth pathways with potentially less toxicity. Participants will be randomly assigned to receive either 5 mg or 10 mg of oral everolimus daily, continuously until disease progression, intolerable side effects, or withdrawal of consent. Treatment begins within four weeks of randomization and is taken once daily after breakfast. Clinical evaluations and blood tests occur every four weeks to monitor safety and adverse effects. Imaging scans such as CT or MRI will be performed every three treatment cycles (about every 12 weeks) to assess tumor response according to standard criteria. Throughout the study, patients will have regular medical visits to check for side effects and treatment tolerance. Researchers will measure progression-free survival at 12 months as the main outcome, as well as time to treatment failure and radiological response. Safety will be monitored by recording adverse events and the need for dose adjustments or treatment interruption. The total study duration varies by patient, continuing until tumor progression or other stopping criteria. The trial aims to enroll 100 patients and is sponsored by AC Camargo Cancer Center.

Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors