Efficacy and safety of adjuvant peptide receptor radionuclide therapy after curative surgery of locoregional limited small intestine neuroendocrine neoplasia – a multi-center, prospective, open-label, two-arm parallel group, randomized, controlled, phase III study

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518236-36-00

Acronym

KKS-312

Enrollment

160

Registered

2025-07-14

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-19

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

Conditions

Locoregionally restricted (stage III) small intestinal neuroendocrine neoplasms (SI-NEN)

Brief summary

RFS will be defined as the time from randomization to first relapse or death, whichever occurs earlier (acc. to ENETS guidelines). Relapse is defined as newly detected lesion with SSTR uptake in PET-CT.

Detailed description

Overall Survival (OS) and cancer-specific OS will be defined as the time from randomization to death/ cancer-specific death., AEs/SAEs, HRQOL will be measured by means of EORTC QLQ-C30/ GINET21 questionnaires.

Interventions

DRUGLutathera 370 MBq/mL solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
RFS will be defined as the time from randomization to first relapse or death, whichever occurs earlier (acc. to ENETS guidelines). Relapse is defined as newly detected lesion with SSTR uptake in PET-CT.	—

Secondary

Measure	Time frame
Overall Survival (OS) and cancer-specific OS will be defined as the time from randomization to death/ cancer-specific death., AEs/SAEs, HRQOL will be measured by means of EORTC QLQ-C30/ GINET21 questionnaires.	—

Countries

Germany

Outcome results

None listed

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