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NCT05235165 · ClinicalTrials.gov registry record · Phase 3
Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
A Phase 3 study of Osteosarcoma and Metastatic Malignant Neoplasm in the Lung, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
- 20
- Study locations
NCT05235165: Recruiting Phase 3 study of Osteosarcoma and Metastatic Malignant Neoplasm in the Lung, sponsored by Children's Oncology Group.
NCT05235165 is a Phase 3 study of Osteosarcoma and Metastatic Malignant Neoplasm in the Lung that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 62 participants, below the 300-participant average among 46 other Osteosarcoma trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05235165, a Phase 3 study of Osteosarcoma and Metastatic Malignant Neoplasm in the Lung, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.
Primary Outcome
Estimated four year thoracic event free survival (tEFS) where tEFS is calculated as the time from study enrollment to thoracic cavity event. Any recurrence within the pulmonary parenchyma, involving the pleural surface or the drain/surgical site wound will be considered an event. A death that results from the procedure, as confirmed by the treating physician, will be considered an event. Patients with recurrences arising outside the thoracic region, the diagnosis of a malignancy that is not oste
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- OTHER Questionnaire Administration
- PROCEDURE Thoracoscopy
- PROCEDURE Thoracotomy
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- PCR Oncology - Arroyo Grande
- Kaiser Permanente-Bellflower - Bellflower
- Kaiser Permanente Downey Medical Center - Downey
- Kaiser Permanente-Fontana - Fontana
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Valley Children's Hospital - Madera
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
Arizona
- Kingman Regional Medical Center - Kingman
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Alabama
- Children's Hospital of Alabama - Birmingham
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2031-03-31 |
| Phase | Phase 3 |
What NCT05235165 shows while recruiting
NCT05235165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 300-participant average among 46 other Osteosarcoma trials with a reported enrollment target (79% lower).
The record links to 3 conditions, with Osteosarcoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05235165 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT05235165 about?
NCT05235165 is a clinical study titled "Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma". This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a...
What is the current status of trial NCT05235165?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2022-04-01. Estimated completion is 2031-03-31.
What conditions does trial NCT05235165 study?
This clinical trial studies the following conditions: Osteosarcoma, Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma.
What interventions are being tested in trial NCT05235165?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Questionnaire Administration (OTHER), Thoracoscopy (PROCEDURE), Thoracotomy (PROCEDURE).
Who is sponsoring clinical trial NCT05235165?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05235165 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteosarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05235165's enrollment target sits among peer trials
62 17th of 46 higher than 30 of 46 other Osteosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteosarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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