Trial · NCT05513365
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 | Overall Response Rate (ORR) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | Response will be measured according to RECIST version 1.1, the ORR is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient. |
| Primary | Duration of Response (DoR) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | Response will be measured according to RECIST version 1.1, the DoR is defined as the time from first tumor assessment at which the overall response was recorded as partial response (PR) or complete response (CR) that is subsequently confirmed until documented progressive disease (PD) or death form any cause, whichever occurs first. |
| Secondary | Progression Free Survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | Response will be measured according to RECIST version 1.1, the PFS is defined as the time from study enrolment until date of first documented disease progression or death due to any cause, whichever occurs first.Every 12 weeks a CT/MRI scan will be made to asses the progression free survival until PD. |
| Secondary | Clinical benefit rate (CBR) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | Response will be measured according to RECIST version 1.1, the CBR is defined as the confirmed CR or PR at any time or stable disease (SD) of at least 6 months. Every 12 weeks a CT/MRI scan will be made to asses the clinical benefit rate until PD. |
| Secondary | Overall survival (OS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years | The OS is defined as the time from study enrolment to the date of death to any cause. |
| Secondary | Quality of Life (QoL) based on the EORTC QLQ-C30 questionnaire | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | Quality of Life (QoL) based on the EORTC QLQ-C30 questionnaire. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD. |
| Secondary | Quality of Life (QoL) based on the EORTC QLQ-H&N43 questionnaire | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | Quality of Life (QoL) based on the EORTC QLQ-H\&N43 questionnaire. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD. |
| Secondary | Quality of Life (QoL) based on the EORTC QLQ-SHQ22 questionnaire | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | Quality of Life (QoL) based on the EORTC QLQ-SHQ22 questionnaire. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD. |
| Secondary | Pain level assessed by the VAS (visual analog scale) questionnaire | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | Scale range 0-10, in which a higher score represents more pain. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD. |
| Secondary | Adverse Events according to CTCAE v5.0 | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | Adverse events will be recorded using International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, the investigator will assess whether those events are drug related. Every OPD visit (every 3 months until PD) |
| Secondary | Circulating tumor DNA (ctDNA) levels | through study completion, estimated after 3 years | ctDNA levels will be assessed to evaluate whether treatment response and disease progression can be predicted. Baseline, 3 months, 6 months, and at PD. |
| Secondary | mRNA expression levels of AR and AR splice variants | through study completion, estimated after 3 years | mRNA expression of AR and AR splice variants on baseline and post-treatment tumor tissue samples to evaluate whether treatment response and disease progression can be predicted. Pre-treatment and post-treatment (i.e. PD) |
| Secondary | mRNA expression levels of SRD5A1/SRD5A2 | through study completion, estimated after 3 years | mRNA expression of SRD5A1/SRD5A2 on baseline and post-treatment tumor tissue samples to evaluate whether treatment response and disease progression can be predicted. Pre-treatment and post-treatment (i.e. PD) |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05513365/registered