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NCT06647953 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Pleuropulmonary Blastoma, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 110
- Enrollment target
- 20
- Study locations
NCT06647953 is a Phase 3 study of Pleuropulmonary Blastoma that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 110 participants, below the 1,685-participant average among 3 other Pleuropulmonary Blastoma trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT06647953, a Phase 3 study of Pleuropulmonary Blastoma, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 110 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial tests how well surgery plus chemotherapy compared to surgery alone works in treating patients with type I pleuropulmonary blastoma (PPB), and tests how well surgery plus standard chemotherapy with the addition of topotecan works compared to surgery plus standard chemotherapy alone in treating patients with type II and III PPB. Historically, most children with type I PPB had surgery and approximately 40% of children with type I PPB received chemotherapy following their surgery, usually for 22-42 weeks. There has not been a consistent standard for which children with type I PPB receive chemotherapy after surgery. For patients whose tumor has been removed completely with surgery, observation without chemotherapy may work as well as giving chemotherapy after surgery in preventing a return of the PPB tumor. The standard chemotherapy for patients with types II or III PPB in the United States is four cycles of IVADo (ifosfamide, vincristine, dactinomycin, and doxorubicin) followed by 8 cycles of IVA (ifosfamide, vincristine and dactinomycin). Ifosfamide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Topotecan is in a class of medications called topoisomerase I inhibitors. It works by interfering with tumor cell DNA which kills them. Giving topotecan in addition to standard IVADo and IVA chemotherapy regimens may shrink the cancer as well as or bette
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Bone Scan
Study Locations (20)
Florida
- Golisano Children's Hospital of Southwest Florida - Fort Myers
- Nemours Children's Clinic-Jacksonville - Jacksonville
- Nicklaus Children's Hospital - Miami
- Arnold Palmer Hospital for Children - Orlando
- Nemours Children's Hospital - Orlando
- Nemours Children's Clinic - Pensacola - Pensacola
- Saint Joseph's Hospital/Children's Hospital-Tampa - Tampa
California
- Loma Linda University Medical Center - Loma Linda
- Children's Hospital Los Angeles - Los Angeles
- Valley Children's Hospital - Madera
- Kaiser Permanente-Oakland - Oakland
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver
Alabama
- Children's Hospital of Alabama - Birmingham
Arizona
- Phoenix Childrens Hospital - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
Delaware
- Alfred I duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2025-03-21 |
| Est. Completion | 2029-03-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06647953
The ClinicalTrials.gov registry entry for NCT06647953 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,685-participant average among 3 other Pleuropulmonary Blastoma trials with a reported enrollment target (93% lower). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pleuropulmonary Blastoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT06647953 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT06647953 about?
NCT06647953 is a clinical study titled "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". This phase III trial tests how well surgery plus chemotherapy compared to surgery alone works in treating patients with type I pleuropulmonary blastoma (PPB), and tests how well surgery plus standard chemotherapy with the addition of topotecan works compared to surgery plus standard chemotherapy alo...
What is the current status of trial NCT06647953?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 110 participants. The study started on 2025-03-21. Estimated completion is 2029-03-31.
What conditions does trial NCT06647953 study?
This clinical trial studies the following conditions: Pleuropulmonary Blastoma.
What interventions are being tested in trial NCT06647953?
The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Bone Scan (PROCEDURE).
Who is sponsoring clinical trial NCT06647953?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06647953 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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