Randomized Interval Assessment trial of Lu177-Dotatate every 8 versus every 16 weeks in slowly progressive G1-2 advanced midgut neuroendocrine tumors (NETs) to Lower TOxicity.

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517921-14-00

Acronym

RLTTio2023

Enrollment

158

Registered

2025-03-17

Start date

2025-05-07

Completion date

Unknown

Last updated

2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine tumors of midgut origin

Brief summary

The primary endpoint for the RIALTO trial is the rate of Grade 2-5 hematological toxicity (worst per patient) from initiation of treatment with RLT up to 24 months thereafter according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5)

Interventions

DRUGLutathera 370 MBq/mL solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint for the RIALTO trial is the rate of Grade 2-5 hematological toxicity (worst per patient) from initiation of treatment with RLT up to 24 months thereafter according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5)	—

Countries

France, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026