FindTrial
Sign In

The evaluation of the effectiveness, safety and tolerability of treatment, using a specialized prostate-specific membrane antigen (PSMA) labeled with Lutetium177, in patients with recurrent and/or metastatic adenoid cystic carcinoma originating from the salivary glands - an open, non-commercial clinical trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504699-73-00
Acronym
LuRM_ACC/2023
Enrollment
32
Registered
2023-09-04
Start date
Unknown
Completion date
2025-04-03
Last updated
2024-01-12

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

Conditions

Adenoid cystic carcinoma

Brief summary

Assessment of safety and tolerability of treatment according to Common Terminology Criteria for Adverse Events (CTCAE v. 5.0)

Detailed description

Objective response rate (ORR) – assessment in CT scan according to RECIST 1.1 score – 2 years after completion of the treatment, Progression free survival (PFS) - assessed from the start of treatment to the time of disease progression or death, Overall survival (OS) – assessed from the start of treatment to the time of death, Duration of response (DoR) – assessed from inclusion in the study to the time of progression or death in patients who achieved a complete or partial response - only patients in remission will have this parameter assessed, Quality of life assessment (according to EORTC QLQ-C30 and EORTC QLQ-H&N43 questionnaires) – assessed from enrollment in the study to 2 years after completion of the treatment

Interventions

DRUGPluvicto 1 000 MBq/mL solution for injection/infusion

Sponsors

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy, Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Assessment of safety and tolerability of treatment according to Common Terminology Criteria for Adverse Events (CTCAE v. 5.0)—

Secondary

MeasureTime frame
Objective response rate (ORR) – assessment in CT scan according to RECIST 1.1 score – 2 years after completion of the treatment, Progression free survival (PFS) - assessed from the start of treatment to the time of disease progression or death, Overall survival (OS) – assessed from the start of treatment to the time of death, Duration of response (DoR) – assessed from inclusion in the study to the time of progression or death in patients who achieved a complete or partial response - only patients in remission will have this parameter assessed, Quality of life assessment (according to EORTC QLQ-C30 and EORTC QLQ-H&N43 questionnaires) – assessed from enrollment in the study to 2 years after completion of the treatment—

Countries

Poland

Outcome results

None listed

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