Trial · NCT07087860
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate (ORR) (Groups A and B) | Up to 6 months | ORR is defined as proportion of evaluable patients with complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. |
| Primary | ORR (Cohort C) | Up to 6 months | ORR is defined as proportion of evaluable patients with complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. |
| Secondary | Duration of response (DOR) (Groups A and B) | Up to 5 years | Duration of response is defined as the time from date of objective response (CR or PR) to date of progression per RECIST 1.1 or death due to all causes, whichever occurs first. |
| Secondary | DOR (Cohort C) | Up to 5 years | Duration of response is defined as the time from date of objective response (CR or PR) to date of progression per RECIST 1.1 or death due to all causes, whichever occurs first. |
| Secondary | Overall survival (OS) (Groups A and B) | Up to 5 years | OS is defined as the time from the date of randomization to the date of death due to all causes. |
| Secondary | OS (Cohort C) | Up to 5 years | OS is defined as the time from the date of randomization to the date of death due to all causes. |
| Secondary | Progression-free survival (PFS) (Groups A and B) | Up to 5 years | PFS is defined as the time from the date of study randomization (assignment to study arm) to the date of death due to all causes or disease progression per RECIST 1.1. |
| Secondary | PFS (Cohort C) | Up to 5 years | PFS is defined as the time from the date of study randomization (assignment to study arm) to the date of death due to all causes or disease progression per RECIST 1.1. |
| Secondary | Incidence of adverse events (AEs) (Groups A and B) | Up to 5 years | AEs will be assessed per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Secondary | Incidence of AEs (Cohort C) | Up to 5 years | AEs will be assessed per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Secondary | Quality of life - EORTC QLQ-CIPN20 (Groups A and B) | Baseline; every 12 weeks (every 4 cycles) until treatment completion, up to 5 years | Quality of life will be measured by change in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy 20 (QLQ-CIPN20) scores, a 20-item questionnaire used to assess the severity of neuropathy symptoms experienced by cancer patients during the past week. Questions are answered on a scale of 1-4 where 1=not at all, 2= a little, 3=quite a bit, and 4=very much. Higher scores indicate greater severity of symptoms. |
| Secondary | Quality of life - EORTC QLQ-CIPN20 (Cohort C) | Baseline; every 12 weeks (every 4 cycles) until treatment completion, up to 5 years | Quality of life will be measured by change in EORTC QLQ-CIPN20 scores, a 20-item questionnaire used to assess the severity of neuropathy symptoms experienced by cancer patients during the past week. Questions are answered on a scale of 1-4 where 1=not at all, 2= a little, 3=quite a bit, and 4=very much. Higher scores indicate greater severity of symptoms. |
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.
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GET https://conductscience.org/api/trials/v1/NCT07087860/registered