Trial · NCT04291300
Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients
NCT04291300, Phase 2, Completed, Radboud University Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients. Trials, record NCT04291300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04291300
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients
- NCT number
- NCT04291300
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Radboud University Medical Center
- Conditions
- Salivary Gland Cancer, Salivary Duct Carcinoma, Adenoid Cystic Carcinoma
- Interventions
- Lutetium-177-PSMA-I&T
- First posted
- 2020-03-02
- Last updated
- 2023-05-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse events measured using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Through study completion, up until 3 years after last patient commences treatment | Safety |
| Secondary | Objective response rate (ORR) | Through study completion, up until 3 years after last patient commences treatment | Response will be measured according to RECIST version 1.1 |
| Secondary | Progression free survival (PFS) | Through study completion, up until 3 years after last patient commences treatment | PFS will be defined as time from study enrollment until disease progression or death. |
| Secondary | Overall survival (OS) | Through study completion, up until 3 years after last patient commences treatment | OS will be defined as time from study enrollment until date of death of any cause. |
| Secondary | Duration of response (DoR) | Through study completion, up until 3 years after last patient commences treatment | Only patients with complete remission or partial response will be included in the assessment of DoR. DoR is defined as time from study enrollment until disease progression or death |
| Secondary | Quality of life (QoL) | Trough study completion, up until 3 years after last patient commences treatment | QoL will be assessed using EORTC QLQ-C30 questionnaire. This is the core questionnaire for assessing health related quality of life of cancer patients participating in clinical trials. It contains 30 items and incorporates a global health status scale, five functional scales, three symptom scales, and several single items assessing additional symptoms. All of the scales and single-item measures range from 0-100. A high score for global health status represents a high QoL, a high score in functional scale represents a high/healthy level of functioning, a high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Secondary | Quality of life (QoL) | Trough study completion, up until 3 years after last patient commences treatment | QoL will be assessed using EORTC QLQ-H\&N43 questionnaire. This is an additional questionnaire to assess health related topics relevant for head and neck cancer patients. The module contains 43 questions, all symtom scales or symptom items.All of the scale/item measures range from 0-100. For all scales/items higher scores indicate more problems. |
| Secondary | Quality of life (QoL) | Trough study completion, up until 3 years after last patient commences treatment | QoL will be assessed using performance status scale for head\&neck cancer patients (PSS-HN). It contains 3 items, each randing from 0-100. These items are rated by the health professional. A high score indicates a high performance status. |
| Secondary | Quality of life (QoL) | Trough study completion, up until 3 years after last patient commences treatment | QoL will be assessed using pain visual analogue scale (VAS) questionnaire. This include two questions: the average pain during the past week and the worst pain during the past week. Both questions range from 0-100, a higher score indicates more pain. |
| Secondary | Dosimetry | From start of study till last patient commences last SPECT/CT (7 days after first treatment cycle) | Delivered doses will be calculated based on pharmacokinetics in the blood and dosimetry on SPECT/CT imaging. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04291300
GET https://conductscience.org/api/trials/v1/NCT04291300/registered