High-Grade OsteosarcomaNCT07878364
Treatment Patterns and Survival Outcomes in High-Grade Osteosarcoma: A Multicenter Retrospective Study
An observational study of High-Grade Osteosarcoma, run by MedPacto, Inc. at 4 sites in South Korea.
Trial summary
This is a multicenter, medical-record-based, retrospective observational study of approximately 400 patients with high-grade osteosarcoma treated at four sites in the Republic of Korea. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- High-Grade Osteosarcoma
- How many people
- 400 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 13 Jul 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with pathologically confirmed high-grade osteosarcoma who completed or ended first-line treatment at one of the four participating institutions on or before 2021-06-30, identified via retrospective EMR review.
Who may be able to join
- Pathologically diagnosed high-grade osteosarcoma; age ≥12 years.
- First-line treatment for high-grade osteosarcoma completed or ended at the study institution on or before 2021-06-30.
- Core data required for survival endpoint assessment (EFS, PFS, OS) are available, with at least one of the following satisfied: (a) at least 12 months of follow-up from the date of diagnosis; or (b) an event (relapse, metastasis, disease progression, or death from any cause) confirmed within 12 months of diagnosis.
Who cannot join
- Primary tumor of soft-tissue origin rather than bone, confirmed pathologically.
- History of a malignancy other than primary osteosarcoma, unless clinically insignificant and fully treated prior to osteosarcoma diagnosis with no investigator-judged impact on osteosarcoma treatment course or survival analysis.
- Core data required for survival analysis cannot be verified.
- Transferred to another institution with no available follow-up information, where neither event occurrence, last follow-up date, nor survival status can be determined from pre-transfer records.
- Investigator-judged data errors or inconsistencies
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
National Cancer Center
Goyang-si
Prof. June-Hyuk Kim
- Not yet recruiting
Asan Medical Center
Seoul
Prof. Kyung-Nam Koh
- Recruiting
Korea Cancer Center Hospital
Seoul
Prof. Wan-Hyeong Cho
- Not yet recruiting
Seoul National University Hospital
Seoul
Prof. Hyoung-Jin Kang
About this study
Official title: A Multicenter Medical-Record-Based Retrospective Study of Treatment Patterns and Survival Outcomes in Patients With High-Grade Osteosarcoma
This is a multicenter, medical-record-based, retrospective observational study of approximately 400 patients with high-grade osteosarcoma treated at four sites in the Republic of Korea. The study describes treatment patterns and survival outcomes (event-free survival [EFS], progression-free survival [PFS], and overall survival [OS]) in patients who completed or discontinued first-line treatment for high-grade osteosarcoma, irrespective of complete remission status. The primary objective is to retrospectively estimate the 12-month EFS rate, calculated from the date of diagnosis, in the full cohort of high-grade osteosarcoma patients. Key secondary objectives evaluate EFS and OS from the date of confirmed complete remission/no evidence of disease (CR/NED) in the subset of clinically high-risk patients who achieve CR/NED, in order to establish a historical reference data supporting the design and interpretation of a future prospective clinical trial of vactosertib as maintenance therapy.
Read the detailed description
High-grade osteosarcoma is the most common primary malignant bone tumor in children, adolescents, and young adults and is treated as a systemic disease requiring multimodal therapy (neoadjuvant chemotherapy, wide surgical resection, and adjuvant chemotherapy). Despite standard multimodal treatment established by trials such as the Multi-Institutional Osteosarcoma Study (MIOS), approximately 30-40% of patients relapse within 2 years, and outcomes remain particularly poor among patients with predefined clinically high-risk features: (1) primary tumor of the axial skeleton, (2) age ≥40 years at diagnosis, (3) pulmonary metastasis (M1a, AJCC 8th edition) at diagnosis, and (4) tumor necrosis rate <90% after neoadjuvant chemotherapy.
No maintenance therapy is currently established for high-risk osteosarcoma patients who achieve complete remission, and an appropriate historical control cohort for designing and interpreting a single-arm maintenance-therapy trial is lacking. This study addresses that gap by retrospectively characterizing survival outcomes in the overall high-grade osteosarcoma population and, separately, in the clinically high-risk subset that achieves CR/NED, anchored to the CR/NED confirmation date. Data will be abstracted from electronic medical records at each site by trained personnel, pseudonymized, and entered into a standardized electronic case report form (eCRF). Two independent reviewers will verify eligibility and key survival-related data. Kaplan-Meier methodology will be used for time-to-event estimates, with 95% confidence intervals derived via the Greenwood formula and log(-log) transformation; Multivariable Cox proportional hazards modeling will be used for exploratory prognostic factor analysis. No formal hypothesis testing against a prespecified benchmark is performed, as this is a descriptive, non-comparative retrospective cohort study.
- Conditions
- High-Grade Osteosarcoma
- Keywords
- Osteosarcoma, Event-free survival, Historical control, Retrospective cohort, Clinically high-risk factors, Complete remission, Maintenance therapy
- Medical subject headings
- Osteosarcoma, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High-grade Osteosarcoma Cohort | Retrospectively identified patients with high-grade osteosarcoma who meet the study eligibility criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month Event-Free Survival (EFS) rate
Estimated by the Kaplan-Meier method in the Full Cohort Set (FCS), calculated from the date of pathological diagnosis regardless of complete-remission status. An event is defined as relapse, new metastasis, disease progression, or death from any cause, whichever occurs first; patients without an event are censored at the date of last confirmed event-free status. 95% CI derived via the Greenwood formula with log(-log) transformation. No hypothesis testing against a prespecified threshold is performed.
Measured: From date of diagnosis to 12 months
Secondary outcomes (9)
12-month EFS rate in CR/NED Set
Kaplan-Meier EFS rate anchored to CR/NED confirmation date, in CHRS patients achieving CR/NED after first-line or ≥2nd-line treatment.
Measured: From CR/NED confirmation date to 12 months
EFS rate at additional timepoints in CR/NED Set
Kaplan-Meier EFS rate at 6, 24, and 36 months from CR/NED confirmation date.
Measured: 6, 24, 36 months from CR/NED confirmation date
Overall Survival (OS) in CR/NED Set
Time from CR/NED confirmation date to death from any cause; median OS with 95% CI (Brookmeyer-Crowley method) where estimable.
Measured: From CR/NED confirmation date until death or last confirmed alive date, assessed up to 17 years.
OS rate at multiple timepoints in CR/NED Set
Kaplan-Meier OS rate at 12, 24, 36, 48, and 60 months from CR/NED confirmation date.
Measured: 12, 24, 36, 48, 60 months from CR/NED confirmation date
Progression-Free Survival (PFS) in FCS
Time from diagnosis to disease progression or death from any cause in the Full Cohort Set; median PFS with 95% CI where estimable.
Measured: From diagnosis until progression, death, or last confirmed alive date, assessed up to 17 years.
PFS rate at multiple timepoints in FCS
Kaplan-Meier PFS rate at 6, 12, 24, 36, 48, and 60 months from diagnosis.
Measured: 6, 12, 24, 36, 48, 60 months from diagnosis
Overall Survival (OS) in FCS
Time from diagnosis to death from any cause in the Full Cohort Set; median OS with 95% CI where estimable.
Measured: From diagnosis until death or last confirmed alive date, assessed up to 17 years.
OS rate at multiple timepoints in FCS
Kaplan-Meier OS rate at 6, 12, 24, 36, 48, and 60 months from diagnosis.
Measured: 6, 12, 24, 36, 48, 60 months from diagnosis
Exploratory prognostic factor analysis
Multivariate Cox proportional hazards modeling of independent prognostic effects of high-risk factors, remission status, stage, age, tumor site, and number of relapses on EFS/PFS/OS; performed in FCS with optional subgroup analyses in CHRS and/or CR/NED Set.
Measured: From diagnosis or CR/NED confirmation date to the applicable event or censoring date, assessed up to 17 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start13 Jul 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Grade OsteosarcomaStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedPacto, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878364
- Sponsor's protocol ID
- MP-VAC-R213
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results are planned for presentation at international scientific conferences (poster or oral) and subsequent submission to a peer-reviewed journal in the field. All presentation and manuscript materials will undergo institutional review prior to submission. Anonymized data may be used to support future meta-analyses or the design of a subsequent maintenance-therapy study.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Medical-Record-Based Retrospective Study of Treatment Patterns and Survival Outcomes in Patients With High-Grade Osteosarcoma
- ClinicalTrials.gov ID
- NCT07878364
- Acronym / sponsor ID
- MP-VAC-R213
- Conditions
- High-Grade Osteosarcoma
- Keywords
- Osteosarcoma, Event-free survival, Historical control, Retrospective cohort, Clinically high-risk factors, Complete remission, Maintenance therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- MedPacto, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Oct 2026 (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.
This is a multicenter, medical-record-based, retrospective observational study of approximately 400 patients with high-grade osteosarcoma treated at four sites in the Republic of Korea. The study describes treatment patterns and survival outcomes (event-free survival [EFS], progression-free survival [PFS], and overall survival [OS]) in patients who completed or discontinued first-line treatment for high-grade osteosarcoma, irrespective of complete remission status. The primary objective is to retrospectively estimate the 12-month EFS rate, calculated from the date of diagnosis, in the full cohort of high-grade osteosarcoma patients. Key secondary objectives evaluate EFS and OS from the date of confirmed complete remission/no evidence of disease (CR/NED) in the subset of clinically high-risk patients who achieve CR/NED, in order to establish a historical reference data supporting the design and interpretation of a future prospective clinical trial of vactosertib as maintenance therapy.
Detailed description
High-grade osteosarcoma is the most common primary malignant bone tumor in children, adolescents, and young adults and is treated as a systemic disease requiring multimodal therapy (neoadjuvant chemotherapy, wide surgical resection, and adjuvant chemotherapy). Despite standard multimodal treatment established by trials such as the Multi-Institutional Osteosarcoma Study (MIOS), approximately 30-40% of patients relapse within 2 years, and outcomes remain particularly poor among patients with predefined clinically high-risk features: (1) primary tumor of the axial skeleton, (2) age ≥40 years at diagnosis, (3) pulmonary metastasis (M1a, AJCC 8th edition) at diagnosis, and (4) tumor necrosis rate <90% after neoadjuvant chemotherapy.
No maintenance therapy is currently established for high-risk osteosarcoma patients who achieve complete remission, and an appropriate historical control cohort for designing and interpreting a single-arm maintenance-therapy trial is lacking. This study addresses that gap by retrospectively characterizing survival outcomes in the overall high-grade osteosarcoma population and, separately, in the clinically high-risk subset that achieves CR/NED, anchored to the CR/NED confirmation date. Data will be abstracted from electronic medical records at each site by trained personnel, pseudonymized, and entered into a standardized electronic case report form (eCRF). Two independent reviewers will verify eligibility and key survival-related data. Kaplan-Meier methodology will be used for time-to-event estimates, with 95% confidence intervals derived via the Greenwood formula and log(-log) transformation; Multivariable Cox proportional hazards modeling will be used for exploratory prognostic factor analysis. No formal hypothesis testing against a prespecified benchmark is performed, as this is a descriptive, non-comparative retrospective cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-grade Osteosarcoma Cohort | – | –Retrospectively identified patients with high-grade osteosarcoma who meet the study eligibility criteria. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with pathologically confirmed high-grade osteosarcoma who completed or ended first-line treatment at one of the four participating institutions on or before 2021-06-30, identified via retrospective EMR review.
Key inclusion criteria (3 listed)
- Pathologically diagnosed high-grade osteosarcoma; age ≥12 years.
- First-line treatment for high-grade osteosarcoma completed or ended at the study institution on or before 2021-06-30.
- Core data required for survival endpoint assessment (EFS, PFS, OS) are available, with at least one of the following satisfied: (a) at least 12 months of follow-up from the date of diagnosis; or (b) an event (relapse, metastasis, disease progression, or death from any cause) confirmed within 12 months of diagnosis.
Key exclusion criteria (5 listed)
- Primary tumor of soft-tissue origin rather than bone, confirmed pathologically.
- History of a malignancy other than primary osteosarcoma, unless clinically insignificant and fully treated prior to osteosarcoma diagnosis with no investigator-judged impact on osteosarcoma treatment course or survival analysis.
- Core data required for survival analysis cannot be verified.
- Transferred to another institution with no available follow-up information, where neither event occurrence, last follow-up date, nor survival status can be determined from pre-transfer records.
- Investigator-judged data errors or inconsistencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
12-month Event-Free Survival (EFS) rate
Time frame: From date of diagnosis to 12 months
Estimated by the Kaplan-Meier method in the Full Cohort Set (FCS), calculated from the date of pathological diagnosis regardless of complete-remission status. An event is defined as relapse, new metastasis, disease progression, or death from any cause, whichever occurs first; patients without an event are censored at the date of last confirmed event-free status. 95% CI derived via the Greenwood formula with log(-log) transformation. No hypothesis testing against a prespecified threshold is performed.
9 secondary outcomes
12-month EFS rate in CR/NED Set
Time frame: From CR/NED confirmation date to 12 months
EFS rate at additional timepoints in CR/NED Set
Time frame: 6, 24, 36 months from CR/NED confirmation date
Overall Survival (OS) in CR/NED Set
Time frame: From CR/NED confirmation date until death or last confirmed alive date, assessed up to 17 years.
OS rate at multiple timepoints in CR/NED Set
Time frame: 12, 24, 36, 48, 60 months from CR/NED confirmation date
Progression-Free Survival (PFS) in FCS
Time frame: From diagnosis until progression, death, or last confirmed alive date, assessed up to 17 years.
PFS rate at multiple timepoints in FCS
Time frame: 6, 12, 24, 36, 48, 60 months from diagnosis
Overall Survival (OS) in FCS
Time frame: From diagnosis until death or last confirmed alive date, assessed up to 17 years.
OS rate at multiple timepoints in FCS
Time frame: 6, 12, 24, 36, 48, 60 months from diagnosis
Exploratory prognostic factor analysis
Time frame: From diagnosis or CR/NED confirmation date to the applicable event or censoring date, assessed up to 17 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. Results are planned for presentation at international scientific conferences (poster or oral) and subsequent submission to a peer-reviewed journal in the field. All presentation and manuscript materials will undergo institutional review prior to submission. Anonymized data may be used to support future meta-analyses or the design of a subsequent maintenance-therapy study.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High-Grade Osteosarcoma, run by MedPacto, Inc. at 4 sites in South Korea.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sumin Kim (+82 10 9743 0118, sumin.kim@medpacto.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month Event-Free Survival (EFS) rate (time frame: From date of diagnosis to 12 months). 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 16 Oct 2026.