Metastatic SarcomaTARGET-RTNCT06796543
Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients With Soft Tissue and Bone Sarcoma
A study testing Consolidative radiation therapy (cRT) in people with Metastatic Sarcoma and Radiation Therapy Patient, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 3 sites in United States.
Trial summary
This study is designed for children, adolescents and young adults undergoing radiation therapy for metastatic sarcoma. The aim of the study is to investigate if the investigators can improve the overall survival of these patients by targeting metastatic sites with radiation. Read more about this study
- Who is it for?
- Ages Up to 39 years
- Conditions the study is for
- Metastatic Sarcoma, Radiation Therapy Patient, Ewing Sarcoma
- What is being tested?
- Consolidative radiation therapy (cRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Mar 2025to Mar 2030
- Phase
- Interventional
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 Up to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Stratum A Inclusion Criteria:
- Patients must be aged < 39 years at time of enrollment.
- Patients must have a Karnofsky or Lansky performance score of 70 or greater or Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Patients must have newly diagnosed histologically or molecularly confirmed soft tissue or bone sarcoma at any site.
- Patients must have metastatic disease that is measurable and this is defined as at least one lesion discontinuous from the primary that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 3mm with CT scan within 3 weeks from treatment start.
Stratum B Inclusion Criteria:
- Patients must have a Karnofsky or Lansky performance score of 70 or greater or ECOG performance status of 0-1.
- Patients must have radiographic, histologic or molecular confirmation of progressive soft tissue or bone sarcoma at any site that was initially diagnosed at age < 39 years. Progression includes progression at a new site or known sites of prior disease (e.g. recurrent).
- Patients must have metastatic disease that is measurable and this is defined as at least one lesion discontinuous from the primary that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 3mm with CT scan
- Radiation to at least one site is being recommended as part of second line therapy.
Stratum A Exclusion Criteria:
- Brain or intracranial metastases, including leptomeningeal disease
- Clinical or radiologic evidence of spinal cord compression requiring emergent radiation treatment
- Positive bone marrow biopsy for non-pelvic primary and greater than eight bone metastases. Presence of parenchymal lung metastases is considered as one metastasis, irrespective of how many lung nodules are present.
- Evidence of any non-measurable metastatic disease including but not limited to leptomeningeal disease, malignant ascites and malignant pleural or pericardial effusions.
- Pregnancy
Stratum B Exclusion Criteria:
- Brain or intracranial metastases, including leptomeningeal disease
- Clinical or radiologic evidence of spinal cord compression requiring emergent radiation treatment
- Evidence of any non-measurable metastatic disease including but not limited to leptomeningeal disease, malignant ascites and malignant pleural or pericardial effusions.
- Pregnancy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Sahaja Acharya, MD, 443-287-7889, sachary7@jhmi.edu
Colette Youstra, MSPH, 2029192533, cyoustr5@jh.edu
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Leslie Chang, MD, 612-273-6014, lechang@umn.edu
Lydia Golden, MPH, 612-301-7797, golde406@umn.edu
- Recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Sahaja Acharya, MD, 443-287-7889, sachary7@jhmi.edu
Colette Youstra, MSPH, 2029192533, cyoustr5@jh.edu
About this study
This study is designed for children, adolescents and young adults undergoing radiation therapy for metastatic sarcoma. The aim of the study is to investigate if the investigators can improve the overall survival of these patients by targeting metastatic sites with radiation.
Read the detailed description
Children, adolescents and young adults (AYA) with metastatic sarcoma have poor event free survival (EFS) and overall survival (OS). Recent retrospective studies suggest there is both an EFS and OS benefit to consolidating all sites of disease with radiation therapy (RT), referred to as consolidative radiation therapy (cRT). However, results from such retrospective studies might be confounded by selection bias as patients with a small burden of metastatic disease are most likely to undergo cRT. Thus far, ongoing prospective studies evaluating the benefit of cRT in the oligometastatic sarcoma setting have been limited to the adults and include sarcoma histologies that are not relevant to children and AYA. Therefore, to address this question in children and AYA, the investigators are proposing a single arm phase II study to estimate the preliminary efficacy of cRT in oligometastatic pediatric bone or soft tissue sarcoma. Given the investigators historical patient population, the investigators expect that approximately 70% of patients enrolled on the study will be diagnosed with either Ewing sarcoma (EWS) or rhabdomyosarcoma (RMS). The investigators primary hypothesis is that the hazard ratio (HR) for EFS of those receiving cRT compared to those did not receive cRT, constructed using historical control data, is less than or equal to 0.5. To address this hypothesis, 32 evaluable patients will need to be enrolled. The investigators will also determine the feasibility of longitudinal quantification of circulating tumor DNA (ctDNA). This may serve as a biomarker of response to therapy and provide additional prognostic value to existing anatomic and metabolic imaging. This trial seeks to enhance outcomes for metastatic sarcoma in the pediatric and AYA setting and may potentially redefine treatment paradigms for this challenging disease.
- Being tested
- Consolidative radiation therapy (cRT)
- Keywords
- Pediatric, Metastatic Sarcoma, Ewing sarcoma, Rhabdomyosarcoma, Brain tumor, Longitudinal, Radiation Therapy
- Medical subject headings
- Sarcoma, Sarcoma, Ewing, Rhabdomyosarcoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consolidative radiation therapy (cRT)Radiation
Treatment that is given after cancer has disappeared following the initial therapy. Consolidation therapy is used to kill any cancer cells that may be left in the body. It may include radiation therapy, a stem cell transplant, or treatment with drugs that kill cancer cells. Also called intensification therapy and postremission therapy.
| Study group | Role | What they receive |
|---|---|---|
| Consolidative radiation therapy (cRT) | Experimental | The therapeutic intervention in Stratum A is consolidative radiation therapy (cRT), which is defined as radiation/surgery to the primary site and radiation to all sites of metastatic disease. All patients enrolled in stratum A will receive standard of care (SOC) induction chemotherapy followed by restaging imaging prior to delivery of cRT. Receives: Radiation: Consolidative radiation therapy (cRT) |
| standard of care (SOC) | No intervention | Patients in Stratum B will undergo standard of care (SOC) second line systemic therapy with radiation to at least one disease site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
2-year event free survival (EFS1) after cRT in patients with oligometastatic sarcoma as compared to historical control (applies to newly diagnosed (Stratum A) patients.
Measured: 2 years
Secondary outcomes (2)
Overall survival (OS)
2-year overall survival (OS) after cRT (applies to newly diagnosed (Stratum A) patients)
Measured: 2 years
Overall Survival (OS) and Event Free Survival (EFS1), stratified by sarcoma histology
To determine differences in overall survival (OS) and event free survival (EFS1) after cRT between EWS, RMS and other sarcoma histologies (applies to newly diagnosed (Stratum A) patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start25 Mar 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic SarcomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- Clark Charitable Foundation Inc.
- Responsible party
- Sponsor
- Investigators
- Sahaja Acharya, MD, Principal investigator, SKCCC Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796543
- Sponsor's protocol ID
- J2489
- Other IDs
- IRB00450219
- Acronym
- TARGET-RT
- Status last verified
- Jul 2026
- First submitted
- 22 Jan 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No