Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients (NCT04291300) | Clinical Trial Compass
CompletedPhase 2
Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients
Netherlands12 participantsStarted 2020-05-26
Plain-language summary
Phase 2 pilot study, which evaluates the safety and efficacy of Lutetium-177-PSMA radioligand therapy in advanced salivary gland cancer patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have the ability to provide written informed consent.
* Patients must be ≥ 18 years of age.
* Patients must have an ECOG performance status of 0 to 2.
* Patients must have histological, pathological, and/or cytological confirmation of either adenoid cystic carcinoma or salivary duct carcinoma.
* Patients must have incurable, local or regional recurrent or metastatic ACC or SDC.
* Patients with ACC can only participate in case of objective growth in the last three months or complaints due to the disease.
* Patients must have adequate organ function:
* Sufficient bone marrow capacity as defined by: WBC count (white blood cell) ≥2.5x10\^9/L, PLT (platelet) count ≥100x10\^9/L, Hb ≥6 mmol/L, absolute neutrophil count (ANC) ≥1.5x10\^9/L
* Adequate liver function as defined by:Total bilirubin ≤1.5 x ULN. For patients known with Gilbert's Syndrome ≤ 3 x ULN is permitted. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN OR ≤5.0 × ULN for patients with liver metastases.
* Adequate kidney function as defined by:serum creatinine ≤1.5 x ULN or creatinine clearance ≥ 50 mL/min
* Patients must have measurable disease at baseline. Defined as ≥ 1 lesion ≥ 2 cm (long axis) that is present on baseline CT.
* Patients must have a positive 68Ga-PSMA PET/CT scan, defined by at least one lesion ≥ 1.5 cm (long axis) with a ligand uptake above liver level.
Exclusion Criteria:
* Patients whom are pregnant or breast feeding.
* P…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events measured using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Timeframe: Through study completion, up until 3 years after last patient commences treatment