Trial · NCT02246127
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | First Progression Free Survival (PFS1) | At 12 months | Proportion of patients who are alive without progression to Course 1 from the date of randomization in STZ based CT vs Everolimus arms Definitions for PFS rate for course 1 at 12 months: * No: number (proportion) of patients who were not alive and progression free according to the respective definition (main, conservative, and optimistic); * Yes: number (proportion) of patients who were alive and progression free according to the respective definition (main, conservative, and optimistic). |
| Secondary | Second Progression Free Survival (Second PFS) | Until the end of study every 12 weeks, approximately up to 5 years | PFS of Course 1 (PFS1) + interval between treatments + PFS of Course 2 (PFS2), where PFS1 represents progression free survival of Course 1 and PFS2 represents progression free survival of Course 2 |
| Secondary | Progression-free Survival (PFS) to First Treatment | Throughout the study period every 12 weeks, approximately up to 5 years | Time from the date of randomization to the date of first disease progression. |
| Secondary | Adverse Events (AEs) Rate | Throughout the study period in continous monitoring at every visit for approximately up to 5 years | Number of patients expiriencing adverse events, treatment-related AEs and serious adverse events (SAEs) |
| Secondary | Frequency of Dose Modifications to First Treatment | Throughout the study period, approximately up to 5 years | Percentage of patients who require a dose reduction or interruption for management of adverse events during the study period |
| Secondary | Best Overall Response (BOR) to First Study Treatment | Throughout the study period, every 12 weeks up to approximately 5 years | Best response achieved with the first study treatment according to RECIST V1.0 |
| Secondary | Objective Response Rate (ORR) to First Study Treatment | Throughout the study period every 12 weeks, up to approximately 5 years | The ORR is defined as the number of patients having as their BOR to first treatment either Complete response (CR) or Partial Response (PR) measured by RECIST criteria version 1.0. |
| Secondary | Frequency of Dose Modifications to Second Treatment | Throughout the study period, approximately up to 5 years | Percentage of patients who require a dose reduction or interruption for management of adverse events during the study period |
| Secondary | Overall Survival (OS) | Throughout the study period, up to approximately 5 years | The median OS defined as the time from the date of randomization until death from any cause. This is estimated by kaplan meier method. |
| Secondary | Best Overall Response (BOR) to Second Study Treatment | Throughout the study period, every 12 weeks up to approximately 5 years | Best response achieved with the second study treatment according to RECIST V1.0 |
| Secondary | Objective Response Rate (ORR) to Second Study Treatment | Throughout the study period every 12 weeks, up to approximately 5 years | The ORR is defined as the number of patients having as their BOR to second treatment either Complete response (CR) or Partial Response (PR) measured by RECIST criteria version 1.0. |
| Secondary | Progression-free Survival (PFS) to Second Treatment | Throughout the study period every 12 weeks, approximately up to 2 years | Time from the date of first dose of second treatment to the date of second disease progression. |
| Other | Quality of Life Questionnaire (QLQ). The EORTC QLQ-C30 Global Health Status | Before any dose of study treatment (basal), before the first dose of the second treatment at line 2 cycle 1 (L2C1) and after completion of both treatments (EOT). See outcome measure description for further details. | Patient self-reported quality of life (QoL) was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire and the specific module for NETs, QLQ-GINET21. These questionnaires have a punctuation that ranges from 100 (best patient performance) to 0 (worse patient performance). Here we report the total QLQ-C30 score. Timepoints: Before any dose of study treatment (basal), before the first dose of the second treatment at line 2 cycle 1 (L2C1) and after completion of both treatments (EOT). Patients changed treatment line and ended both treatments after progression, therefore this outcome is not linked to specific reference timepoints but rather to a relevant disease stage which may happer early or latter in time. All assessments are performed obviously during trial duration, up to approximately 5 years. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT02246127/registered