Trial · NCT04727723
Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs
NCT04727723, Completed, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs. Trials, record NCT04727723. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04727723
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs
- NCT number
- NCT04727723
- Status
- Completed
- Enrollment
- 164 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Gastroenteropancreatic Neuroendocrine Tumor
- Interventions
- Lutathera®
- First posted
- 2021-01-27
- Last updated
- 2026-05-04
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Up to 48 months | PFS, defined as the time, in months, from Lutathera® treatment initiation to the date of first objective tumour progression, determined according to Response Evaluation Criteria in Solid Tumours (RECIST) Criteria, Version 1.1, or death due to any cause, whichever comes first. |
| Secondary | Objective Response Rate (ORR) | Up to 48 months | ORR, defined as the proportion of treated patients who achieve a best overall response of partial response (PR) or complete response (CR) according to RECIST 1.1 |
| Secondary | Duration of Response (DoR), for those patients who achieve a best response of PR or better | Up to 48 months | DoR, defined as the time, in months, from the date when criteria for response are first met until the date of a progression event (according to the primary definition of PFS). |
| Secondary | Clinical Benefit Rate (CBR) | Up to 48 months | CBR, defined as the proportion of treated patients who achieve a best overall response of stable disease (SD), PR or CR according to RECIST 1.1. |
| Secondary | Duration of Clinical Benefit, for those patients who achieve a best response of SD or better | Up to 48 months | Duration of clinical benefit, defined as the time, in months, from the date when criteria for clinical benefit are first met until the date of a progression event (according to the primary definition of PFS). |
| Secondary | Time to Progression (TTP) | Up to 48 months | TTP, defined as the time, in months, from Lutathera® treatment initiation to the date of first objective tumour progression, assessed according to RECIST 1.1. |
| Secondary | Assess the impact of treatment on health-related Quality of Life (HRQoL) by EORTC QLQ-C30 questionnaire | Up to 48 months | EORTC QLQ-C30 will be filled in by the patient prior to knowing computed tomography (CT) scan/magnetic resonance imaging (MRI) result. The EORTC QLQ-C30 questionnaire is designed for use with a wide range of cancer patient populations and is intended to be supplemented by tumour-specific questionnaire modules. The EORTC QLQ-C30 incorporates different multi-item scales, i.e. functional scales, symptom scales and a Global Health Status/QoL scale. All parameters are evaluated using single or multi-item questions which are consequently converted into a 100-point score. |
| Secondary | Assess the impact of treatment on health-related Quality of Life (HRQoL) by EORTC QLQ-G.I.NET-21 questionnaire | Up to 48 months | EORTC QLQG. I.NET-21 will be filled in by the patient prior to knowing computed tomography (CT) scan/magnetic resonance imaging (MRI) result. EORTC QLQ-G.I.NET-21 questionnaire is a module specific for neuroendocrine tumours and comprises 21 questions assessing disease symptoms, side effects of treatment, body image, disease related worries, social functioning, communication and sexuality. Each subscale is based on the following items: endocrine scale (items 31-33); gastrointestinal scale (34-38); treatment scale (39, 40, and 46); social function scale (42, 44, and 49); disease related worries scale (41, 43, and 47); muscle/bone pain (48), sexual function (51), information/communication function (50), and body image (45). All parameters are evaluated using single or multi-item questions which are consequently converted into a 100-point score |
| Secondary | Time to Deterioration (TTD) in global health scale (TTD- global health scale) | Baseline, up to 48 months | TTD, defined as the time, in months, from Lutathera® treatment initiation to the date of first deterioration of ≥10 points in the EORTC QLQ-C30 and EORTC QLQ-G.I.NET21 global health scale score compared to the baseline score for the same domain. |
| Secondary | Time to Deterioration (TTD) in diarrhoea item (TTD- diarrhoea item) | Baseline, up to 48 months | TTD, defined as the time, in months, from Lutathera® treatment initiation to the date of first deterioration of ≥10 points in the EORTC QLQ-C30 and EORTC QLQ-G.I.NET21 diarrhoea item score compared to the baseline score for the same domain. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes0
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38772998 | DERIVED |
Source PubMed
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/NCT04727723
GET https://conductscience.org/api/trials/v1/NCT04727723/registered?page=2