Trial · NCT06333821
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 | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed Blinded Independent Central Review (BICR) | Up to approximately 5 years | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. |
| Secondary | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by by the Investigator | Up to approximately 5 years | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. |
| Secondary | 3-,5-Year Overall Survival (OS) | Up to approximately 3 and 5 years | OS is the time from randomization to death due to any cause. |
| Secondary | 3-,5-Year Disease Free Survival(DFS) | Up to approximately 3 and 5 years | DFS is defined as the time from randomization to disease recurrence or death due to any cause. |
| Secondary | 3-,5-Year Locoregional Recurrence-Free Survival(LRRFS) | Up to approximately 3 and 5 years | Locoregional recurrence-free survival (LRRFS) was defined as the absence of either consistent or relapsed disease at the primary tumor site or the regional lymph nodes |
| Secondary | 3-,5-Year Distant Metastasis-free Survival (DMFS) | Up to approximately 3 and 5 years | Distant metastasis-free survival (DMFS) was calculated from the date of patient recruitment to the date of distant metastasis. |
| Secondary | Tumor Regression Rate(TRR) | From date of randomization until the date of brachytherapy,assessed up to 5 weeks | The maximum diameter represents the size of the tumor by MRI. Tumor size for each patient were obtained: pre-RT tumor size (V1), pre- brachytherapy tumor size (V2). TRR=(V1-V2)/V1 × 100%. |
| Secondary | Complete Response Rate | From date of randomization until the date of brachytherapy,assessed up to 5 weeks | The proportion of subjects with the best complete response in this group assessed by MRI. |
| Secondary | Complete Response Rate | 3 months later after treatment | The proportion of subjects with the best complete response in this group assessed by MRI. |
| Secondary | Objective Response Rate | 3 months later after treatment | The proportion of subjects with the best complete response or partial response in this group assessed by MRI. |
| Secondary | Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score | Baseline and up to approximately 5 years | The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The change from baseline in EORTC QLQ-C30 score will be presented. |
| Secondary | Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score | Baseline and up to approximately 5 years | The EORTC QLQ-CX24 is a questionnaire that rates the symptoms common to women with cervical cancer and evaluates the impact of disease and/or treatments. The 24 items use a 4-point scale (1=not at all to 4=very much) and are classified into 3 multi-item scales, 11 items with symptom experience, 3 items with body image, and 4 items with sexual/ vaginal functioning. The other items of the questionnaire are lymphedema, peripheral neuropathy, menopausal symptom, sexual worry, sexual activity, and sexual enjoyment. The change from baseline in EORTC QLQ-CX24 score will be presented. |
| Secondary | Incidence of Treatment-Emergent Adverse Events | Within 30 days from the start of treatment to the end of the last treatment | Safety was assessed as adverse events during treatment, the incidence of various adverse events such as adverse events related to the study drug during treatment, laboratory tests, etc |
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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