Osteosarcoma MetastaticNCT04546243
Osteosarcoma With Resectable Pulmonary Metastasis: A Retrospective Study
An observational study of Osteosarcoma Metastatic and Pulmonary Disease, run by Peking University People's Hospital at 2 sites in China.
Trial summary
According to EURAMOS-1, 17% of osteosarcoma patients were considered to have metastases at diagnosis. In this selected cohort, the reported 5-year EFS from diagnosis of 28% compares well to previous results reported from unselected cohorts of patients with only lung metastases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteosarcoma Metastatic, Pulmonary Disease, Resectable Sarcoma
- What is being tested?
- resection group and radiotherapy group
- Type of treatment
- Surgery or procedure
- How many people
- 127 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2020to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This report includes all the patients with recurrences from a previously treated cohort of 678 consecutive, newly diagnosed patients with localized or primary metastatic high-grade osteosarcoma of the trunk or limbs registered onto the neoadjuvant studies of Peking University People's Hospital and Peking University Shougang Hospital between the end of 2009 and March 2020. Intended first-line treatment included pre- and postoperative chemotherapy according to the PKUPH-OS protocol , as well as surgery of all operable lesions. All protocols prescribed high-dose methotrexate, doxorubicin, cisplatin and ifosfamide in varying combinations.
Who may be able to join
- Histologically confirmed high-grade osteosarcoma reviewed by the Pathology Committee of Peking University People's Hospital
- Pulmonary nodules by Chest CT confirmed by later scan as pulmonary metastasis
- A first complete remission (CR) had been achieved
- Intended first-line treatment included pre- and postoperative chemotherapy according to the PKUPH-OS protocol as well as local therapy of all operable lesions
Who cannot join
- Lost to follow up
- Patients with severe or uncontrolled medical disorders that could jeopardize the outcomes of the study. These confounding conditions included, cardiac clinical symptoms or disease with left ventricular ejection fraction<50%, and hypertension that could not be well controlled with antihypertensive drugs.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100036
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Retrospective Study Investigating Survival for High-grade Osteosarcoma Patients Who Had Achieved First Complete Surgical Remission (SCR) During Combined-modality Therapy in Two Hospitals Affiliated to Peking University
According to EURAMOS-1, 17% of osteosarcoma patients were considered to have metastases at diagnosis. In this selected cohort, the reported 5-year EFS from diagnosis of 28% compares well to previous results reported from unselected cohorts of patients with only lung metastases. Resection of pulmonary metastases from osteosarcoma is a treatment option which has been shown to correlate with survival benefit and cure in select individuals. These patients are best addressed in a multidisciplinary fashion, with the involvement of a thoracic surgeon with experience in pulmonary metastasectomy. At the same time, the goal of surgical resection of pulmonary metastases from osteosarcoma is to render the patient completely disease free. "Tumor debulking" or "cytoreductive surgery" with incomplete resection has not demonstrated any survival benefit for patients with pulmonary metastases. Thus open thoracotomy is more preferred than VATS. However over the last decade in China, thoracotomy has not been adopted generally. More patients had chosen VATS or even hypo-fractionation radiotherapy, such as gamma knife, cyber knife and so on as a local treatment method. This study aims to investigate the survival of consecutive patients who had achieved a first complete surgical remission (CR) during combined-modality therapy on neoadjuvant or adjuvant PKUPH-OS protocol so as to discuss reasonable local therapy for resectable pulmonary osteosarcoma metastatic lesions.
- Being tested
- resection group, radiotherapy group
- Keywords
- osteosarcoma, pulmonary metastasis, resectable, event-free survival
- Medical subject headings
- Lung Diseases, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resection groupProcedure or surgery
patients received VATS
radiotherapy groupRadiation
patients received radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| osteosarcoma patients receiving resections | Not described Receives: Procedure: resection group | |
| osteosarcoma patients receiving radiotherapy | Not described Receives: Radiation: radiotherapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
event-free survival
from local therapy of the pulmonary nodules to any events of progression of disease/last follow-up
Measured: 2 year
Secondary outcomes (2)
local recurrence rate
from local therapy of the pulmonary nodules to local recurrence/last follow-up
Measured: 2 year
overall survival
from local therapy of the pulmonary nodules to death/last follow-up
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start1 Jan 2020
- Primary completion1 Oct 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteosarcoma MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Shougang Hospital
- Responsible party
- Sponsor
- Investigators
- Wei Guo, M.D., Principal investigator, Musculoskeletal Tumor Center of Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546243
- Sponsor's protocol ID
- PKUPH-sarcoma 13
- Status last verified
- Dec 2020
- First submitted
- 4 Sep 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Investigating Survival for High-grade Osteosarcoma Patients Who Had Achieved First Complete Surgical Remission (SCR) During Combined-modality Therapy in Two Hospitals Affiliated to Peking University
- ClinicalTrials.gov ID
- NCT04546243
- Acronym / sponsor ID
- PKUPH-sarcoma 13
- Keywords
- osteosarcoma, pulmonary metastasis, resectable, event-free survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University Shougang Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 11 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to EURAMOS-1, 17% of osteosarcoma patients were considered to have metastases at diagnosis. In this selected cohort, the reported 5-year EFS from diagnosis of 28% compares well to previous results reported from unselected cohorts of patients with only lung metastases. Resection of pulmonary metastases from osteosarcoma is a treatment option which has been shown to correlate with survival benefit and cure in select individuals. These patients are best addressed in a multidisciplinary fashion, with the involvement of a thoracic surgeon with experience in pulmonary metastasectomy. At the same time, the goal of surgical resection of pulmonary metastases from osteosarcoma is to render the patient completely disease free. "Tumor debulking" or "cytoreductive surgery" with incomplete resection has not demonstrated any survival benefit for patients with pulmonary metastases. Thus open thoracotomy is more preferred than VATS. However over the last decade in China, thoracotomy has not been adopted generally. More patients had chosen VATS or even hypo-fractionation radiotherapy, such as gamma knife, cyber knife and so on as a local treatment method. This study aims to investigate the survival of consecutive patients who had achieved a first complete surgical remission (CR) during combined-modality therapy on neoadjuvant or adjuvant PKUPH-OS protocol so as to discuss reasonable local therapy for resectable pulmonary osteosarcoma metastatic lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| osteosarcoma patients receiving resections | – | Procedure: resection group |
| osteosarcoma patients receiving radiotherapy | – | Radiation: radiotherapy group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This report includes all the patients with recurrences from a previously treated cohort of 678 consecutive, newly diagnosed patients with localized or primary metastatic high-grade osteosarcoma of the trunk or limbs registered onto the neoadjuvant studies of Peking University People's Hospital and Peking University Shougang Hospital between the end of 2009 and March 2020. Intended first-line treatment included pre- and postoperative chemotherapy according to the PKUPH-OS protocol , as well as surgery of all operable lesions. All protocols prescribed high-dose methotrexate, doxorubicin, cisplatin and ifosfamide in varying combinations.
Key inclusion criteria (4 listed)
- Histologically confirmed high-grade osteosarcoma reviewed by the Pathology Committee of Peking University People's Hospital
- Pulmonary nodules by Chest CT confirmed by later scan as pulmonary metastasis
- A first complete remission (CR) had been achieved
- Intended first-line treatment included pre- and postoperative chemotherapy according to the PKUPH-OS protocol as well as local therapy of all operable lesions
Key exclusion criteria (2 listed)
- Lost to follow up
- Patients with severe or uncontrolled medical disorders that could jeopardize the outcomes of the study. These confounding conditions included, cardiac clinical symptoms or disease with left ventricular ejection fraction<50%, and hypertension that could not be well controlled with antihypertensive drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resection grouppatients received VATS | Procedure or surgery | osteosarcoma patients receiving resections |
| radiotherapy grouppatients received radiotherapy | Radiation | osteosarcoma patients receiving radiotherapy |
Primary outcome
event-free survival
Time frame: 2 year
from local therapy of the pulmonary nodules to any events of progression of disease/last follow-up
2 secondary outcomes
local recurrence rate
Time frame: 2 year
overall survival
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Guo, M.D. principal investigator
Musculoskeletal Tumor Center of Peking University People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma Metastatic and Pulmonary Disease, run by Peking University People's Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
event-free survival (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.