Trial · NCT06647953
Testing a Standardized Approach to Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma or the Addition of an Anti-cancer Drug, Topotecan, to the Usual Treatment for Types II and III Pleuropulmonary Blastoma
NCT06647953, Phase 3, Recruiting, Children's Oncology Group
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing a Standardized Approach to Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma or the Addition of an Anti-cancer Drug, Topotecan, to the Usual Treatment for Types II and III Pleuropulmonary Blastoma. Trials, record NCT06647953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06647953
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Testing a Standardized Approach to Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma or the Addition of an Anti-cancer Drug, Topotecan, to the Usual Treatment for Types II and III Pleuropulmonary Blastoma
- NCT number
- NCT06647953
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 110 participants, estimated
- Lead sponsor
- Children's Oncology Group
- Conditions
- Pleuropulmonary Blastoma
- Interventions
Biospecimen Collection, Biospecimen Collection, Bone Scan, Computed Tomography, Cyclophosphamide, Dactinomycin, Dexrazoxane, Doxorubicin, Echocardiography Test, Ifosfamide, Magnetic Resonance Imaging, Multigated Acquisition Scan, Patient Observation, Positron Emission Tomography, Topotecan, Ultrasound Imaging, Vincristine
- First posted
- 2024-10-18
- Last updated
- 2026-08-25
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06647953
GET https://conductscience.org/api/trials/v1/NCT06647953/registered