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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05235165




Registration number
NCT05235165
Ethics application status
Date submitted
19/01/2022
Date registered
11/02/2022
Date last updated
22/04/2024

Titles & IDs
Public title
Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Scientific title
A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Secondary ID [1] 0 0
NCI-2021-14237
Secondary ID [2] 0 0
AOST2031
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Malignant Neoplasm in the Lung 0 0
Metastatic Osteosarcoma 0 0
Osteosarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Biospecimen Collection
Treatment: Surgery - Computed Tomography
Other interventions - Questionnaire Administration
Treatment: Surgery - Thoracoscopy
Treatment: Surgery - Thoracotomy

Experimental: Arm A (thoracotomy) - Patients undergo open thoracic surgery (thoracotomy). Patients undergo CT throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial.

Experimental: Arm B (thoracoscopy) - Patients undergo thoracoscopy (video-assisted thoracoscopic surgery or VATS). Patients undergo CT throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial.


Treatment: Surgery: Biospecimen Collection
Undergo collection of tissue and blood

Treatment: Surgery: Computed Tomography
Undergo CT

Other interventions: Questionnaire Administration
Ancillary studies

Treatment: Surgery: Thoracoscopy
Undergo video-assisted thoracoscopic surgery or VATS

Treatment: Surgery: Thoracotomy
Undergo open thoracic surgery
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Thoracic event-free survival (tEFS)
Timepoint [1] 0 0
Four years after enrollment
Secondary outcome [1] 0 0
Event free survival (EFS)
Timepoint [1] 0 0
Four years after enrollment
Secondary outcome [2] 0 0
Overall survival (OS)
Timepoint [2] 0 0
Four years after enrollment
Secondary outcome [3] 0 0
Post operative pain interference at time point 3, 7-14 days after surgical intervention
Timepoint [3] 0 0
7-14 days after surgical intervention
Secondary outcome [4] 0 0
Post operative pain interference at time point 4, 4-6 weeks after surgical intervention
Timepoint [4] 0 0
4-6 weeks after surgical intervention

Eligibility
Key inclusion criteria
- Patients must be < 50 years at the time of enrollment.

- Patients must have =< 4 nodules per lung consistent with or suspicious for metastases,
with at least one of which being >= 3 mm and all of which must be =< 3 cm size.

- Note: Patient must have eligibility confirmed by rapid central imaging review.

- Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic
surgery. Determination of resectability is made by the institutional surgeon.

- Patients must have a histological diagnosis of osteosarcoma.

- Patients must have evidence of metastatic lung disease at the time of initial
diagnosis, or at time of 1st recurrence following completion of therapy for initially
localized disease.

- Patients with newly diagnosed disease must have completed successful gross tumor
resection for their primary tumor or surgical local control of primary tumor must be
planned to be performed simultaneously with thoracic surgery.

- Newly diagnosed patients must be receiving or recently completed (within 60 days)
systemic therapy considered by the treating physician to be standard treatment for
newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug
regimens) at the time of enrollment on this study. Dose and drug modifications for
toxicity do not exclude patients from participation.

- Patients at time of 1st recurrence must have completed systemic therapy for their
initial primary tumor, considered by the treating physician to be standard treatment
for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug
regimens) at the time of enrollment on this study. Dose and drug modifications for
toxicity do not exclude patients from participation.
Minimum age
No limit
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with unresectable primary tumor.

- Patients with pulmonary metastatic lesions that would require anatomic resection
(lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central
lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to
segmental bronchi).

- Patients with chest wall or mediastinal based metastatic lesions, or with significant
pleural effusion.

- Patients with disease progression at either the primary or pulmonary metastatic site
while on initial therapy. Note: Once the patient has been enrolled on the study,
additional computed tomography (CT) scans are not anticipated prior to thoracic
surgery. Note: Some variation in nodule size measurements over the course of
pre-operative therapy is anticipated and does not qualify for exclusion unless deemed
true disease progression by the primary treatment team.

- Patients with evidence of extrapulmonary metastatic disease.

- Patients who received therapeutic pulmonary surgery for lung metastasis prior to
enrollment.

- All patients and/or their parents or legal guardians must sign a written informed
consent.

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2031
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [3] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment postcode(s) [3] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Vermont
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Virginia
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Washington
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West Virginia
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Wisconsin
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Canada
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Alberta
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Canada
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Nova Scotia
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Canada
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Quebec
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New Zealand
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Auckland
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New Zealand
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Christchurch
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Puerto Rico
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Caguas
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Saudi Arabia
State/province [53] 0 0
Riyadh

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05235165
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John J Doski
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05235165