Trial · NCT04727723
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| 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. |
| Secondary | Time to Deterioration (TTD) in fatigue item (TTD- fatigue 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 fatigue item score compared to the baseline score for the same domain. |
| Secondary | Time to Deterioration (TTD) in pain item (TTD- pain 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 pain item score compared to the baseline score for the same domain. |
| Secondary | Number of patients with Adverse Events (AEs) related to study drug | Up to 48 months | Number of patients with Adverse Events (AEs) related to study drug will be reported |
| Secondary | Seriousness and relationship to Lutathera® treatment | Up to 48 months | Seriousness and relationship to Lutathera® treatment will be reported |
| Secondary | Incidence of deaths due to any cause. | Up to 48 months | Incidence of deaths due to any cause will be reported |
| Secondary | Number of participants with notable changes in laboratory parameters | Up to 48 months | Safety measured by the notable post-baseline changes in laboratory parameters compared to baseline. Standard Lab parameters will be reported when performed as clinical practice. |
| Secondary | Number of participants with notable changes in physical examination | Up to 48 months | Safety measured by the notable post-baseline changes in physical examination compared to baseline. Physical examination will be reported when performed as clinical practice. |
| Secondary | Number of participants with notable changes in vital signs | Up to 48 months | Safety measured by the notable post-baseline changes in vital signs compared to baseline. Vital signs will be reported when performed as clinical practice. |
| Secondary | Number of participants with notable changes in electrocardiogram (ECG) | Up to 48 months | Safety measured by the notable post-baseline changes in ECG compared to baseline. ECG results will be reported when performed as clinical practice. |
| Secondary | Changes in Karnofsky Performance Status (KPS) scores | Up to 48 months | KPS scores will be reported when performed as clinical practice. Karnofsky Performance Status (KPS) is a standard way of measuring the ability of cancer patients to perform ordinary tasks. The KPS score ranges from 0 to 100. A higher score means the patient is better able to carry out daily activities. KPS forms must be completed by the treating physician at each treatment and follow-up visit. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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