Trial · NCT06647953
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response | Up to 2 cycles (cycles = 21 days) of window therapy with vincristine, topotecan and cyclophosphamide | Response rates at the end of Cycle 2 will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. Any eligible type II/III patients who do not undergo complete resection, have measurable disease at baseline (per central review) and start protocol therapy will be included in the primary analysis. |
| Secondary | Progression-free survival (PFS) in children with Types II and III pleuropulmonary blastoma (PPB) | From date of enrollment to the earliest occurrence of relapse, disease progression, or death due to any cause, assessed up to 3 years | 3-year PFS, along with the confidence intervals will be estimated using the Kaplan-Meier method. These results will be presented for Type II and III patients combined regardless of the timing of surgery. |
| Secondary | Overall survival (OS) in children with Types II and III PPB | From date of enrollment to date of death due to any reason, assessed up to 3 years | 3-year OS, along with the confidence intervals will be estimated using the Kaplan-Meier method. These results will be presented for Type II and III patients combined regardless of the timing of surgery. |
| Secondary | PFS in children with Types I PPB | From date of enrollment to the earliest occurrence of relapse, disease progression, or death due to any cause, assessed up to 3 years | 3-year PFS, along with the confidence intervals will be estimated using the Kaplan-Meier method. |
| Secondary | OS in children with Types I PPB | From date of enrollment to date of death due to any reason, assessed up to 3 years | 3-year OS, along with the confidence intervals will be estimated using the Kaplan-Meier method. |
| Other | Resection rates for Type I PPB | Prior to protocol therapy | Will be reported based on central radiology reviews. |
| Other | Resection rates for Type II and III PPB | Prior to protocol therapy | Will be reported based on central radiology reviews. |
| Other | Resection rates for Type II and III PPB | Prior to cycle 5 (cycles = 21 days) | Will be reported based on central radiology reviews. |
| Other | Incidence of surgery-related adverse events | Up to 5 years | Percentage of patients with surgery related adverse event. Results will be summarized separately for those undergoing primary resection versus those undergoing biopsy followed by neoadjuvant chemotherapy. |
| Other | Incidence of adverse events | Up to 36 weeks | Percentage of patients with Grade 3 or higher toxicities on protocol therapy. |
| Other | PFS | Up to 5 years | Will use Kaplan-Meier survival curves and log-rank tests to analyze PFS based on DICER1 germline status, hotspot mutations, and p53 status. Additionally, Cox proportional hazards regression will be used to evaluate the influence of these genetic factors on PFS controlling for confounding variables as necessary. |
| Other | Primary outcome treatment effects by sex | Up to 5 years | Estimates of the primary outcome treatment effect and the corresponding 95% confidence intervals (CIs) by sex will be provided. |
| Other | Primary outcome treatment effects by race | Up to 5 years | Estimates of the primary outcome treatment effect and the corresponding 95% CIs by race will be provided. |
| Other | Primary outcome treatment effects by ethnicity | Up to 5 years | Estimates of the primary outcome treatment effect and the corresponding 95% CIs by ethnicity will be provided. |
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/NCT06647953/registered