Trial · NCT04029428
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS - Progression Free Survival (time - months) | up to 8 years | PFS is the time from the date of the start therapy to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. CT or MRI tumour assessment will be used to response evaluation. CT/MRI tumour assessment will be performed before start of PRRT and then after 6+2 weeks after last PRRT session followed by 6 months intervals during first 3 years of follow-up, after that annually. The measurement of PFS will be calculated in months. |
| Secondary | OS - Overall Survival (time months) | up to 8 years | Overall survival is defined as the time from the date of the start therapy to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off. The measurement of OS will be calculated in months. |
| Secondary | Performance Status (PS) - evaluation criteria | up to 8 years | Clinical response based on physical performance status (PS) using standard evaluation based on WHO/ECOG criteria. It will be assessed before each treatment cycle and then followed by 6 weeks after completion of therapy and then at three-month intervals. The measurement will be in the scale as follows: 0-asymptomatic, 1=symptomatic but completely ambulatory, 2=Symptomatic \<50% in bed during the day, 3= Symptomatic \>50% in bed during the day; 4=Bedbound; 5=Death. |
| Secondary | Cancer Related Symptoms - assessment of clinical criteria | From date of first enrollment to the end of the follow-up, overall up to 8 years. | Clinical response based on potential relief in the initial phase before PRRT during and after PRRT. Items will be assessed, including: appetite, malaise, pain associated with the disease, nausea, vomiting, fever, wheezing and abdominal pain or any other symptoms of advanced cancer. All of the above will be assessed as yes / no. Intensity will be recorded in the quality assessment. It will be evaluated before treatment, before each treatment cycle, and then 6 weeks after the end of therapy, and then at three-month intervals. The measurement will be made in the qualitative data set and categorized as improvement, stabilization or disease progression. |
| Secondary | Hormonal overproduction symptoms - assessment of clinical criteria | From date of first enrollment to the end of the follow-up, overall up to 8 years. | Hormonal response based on relief of symptoms of hormonal overproduction, which will be compare to clinical symptoms before PRRT, during and after PRRT during clinical follow-up. The presence of specific symptoms with hormone overproduction including: 1. Carcinoid syndrome (CS) - initial intensity of diarrhea and potential relief after PRRT (number per day), initial intensity of flushing and potential relief after PRRT (number per day). 2. Presence of heartburn in case of NET with ZES (Zollinger-Elisson syndrome) initial intensity and potential relief during PRRT and after finished PRRT during clinical follow-up. 3. Presence of hypoglycemia in case of NET with insulin overproduction (insulinoma), initial intensity of hypoglycemia before PRRT and potential relief after PRRT during clinical follow-up. The measurement will be made in a set of the qualitative data as improvement, stabilization or disease progression. |
| Secondary | ORR - Objective Response Rate - evaluation criteria | from date of first enrollment to the end of the follow-up, overall up to 8 years. | The evaluation of objective response will be utilized by multiphase structural imaging before and after i.v. contrast enhancement (CT or MRI). The radiological response will be based on RECIST 1.0 using standard terminology of objective response, performed before start of PRRT and then after 6+2 weeks after last PRRT therapy followed by 6 months intervals during first 3 years of follow-up, after that annually. The measurement will be made in a set of quantitative data as partial response (PR), stable disease (SD) or disease progression (DP). |
| Secondary | Safety Assessments - Laboratory Parameters - evaluation criteria: CTCAEs ver. 4.0 | from date of first enrollment to the end of the follow-up, overall up to 8 years. | Changes from Baseline in Hematology (WBC, RBC, platelets, haemoglobin), Blood chemistry (BUN, serum creatinine and creatinine clearance, uric acid, albumin, total bilirubin, AP, aspartate aminotransferase \[AST/ASAT\], alanine aminotransferase \[ALT/ALAT\], gamma-glutamyl transferase \[γ-GT\], \[Na\], \[K\], lactic dehydrogenase \[LDH\], glycosylated hemoglobin/hemoglobin A1c \[glycoHb\] and specific biomarkers Chromogranin-A (CgA) in the serum and 5-Hydroxyindoleacetic acid (5-HIAA) in the urine. The measurement will be made in a set of quantitative data, based on CTCAEs ver. 4.0. https://www.eortc.be/services/doc/ctc/CTCAE\_4.03\_2010-06-14\_QuickReference\_5x7.pdf |
| Secondary | Vital Signs - heart rate - physiological parameter | from date of first enrollment to the end of the follow-up, overall up to 8 years. | heart rate (beats per minute) |
| Secondary | Systolic and diastolic blood pressure - physiological parameter | from date of first enrollment to the end of the follow-up, overall up to 8 years. | mmHg. |
| Secondary | BMI - Body Mass Index - physiological parameter | from date of first enrollment to the end of the follow-up, overall up to 8 years. | weight (kg), height (m) Body Mass Index (BMI kg/m2). The measurement will be made in a set of quantitative data. |
| Secondary | ECG - physiological parameter | from date of first enrollment to the end of the follow-up, overall up to 8 years. | ECG analysis during each therapy session and clinical follow-up, including: P Wave, QRS Complex, QT Interval. The measurement will be made in a set of quantitative data. |
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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