Targeted radiation therapy for young patients with metastatic sarcoma
Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients With Soft Tissue and Bone Sarcoma
This study is testing if a special type of radiation therapy can help young patients with metastatic sarcoma live longer and have fewer health issues compared to those who don’t receive it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | N/A to 39 Years |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | Radiation |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT06796543 on ClinicalTrials.gov |
What this trial studies
This study focuses on children, adolescents, and young adults with metastatic sarcoma who are undergoing radiation therapy. The aim is to evaluate whether consolidative radiation therapy (cRT) can improve overall survival by targeting metastatic sites. The study will enroll approximately 32 patients diagnosed primarily with Ewing sarcoma or rhabdomyosarcoma and will compare their outcomes to historical control data. The primary hypothesis is that cRT will significantly enhance event-free survival compared to those who do not receive this treatment.
Who should consider this trial
Good fit: Ideal candidates are patients aged under 39 with newly diagnosed or progressive soft tissue or bone sarcoma and a performance score of 70 or greater.
Not a fit: Patients with non-metastatic sarcoma or those who do not meet the performance status criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates for young patients with metastatic sarcoma.
How similar studies have performed: While similar approaches have shown promise in adult populations, this specific focus on pediatric and young adult patients represents a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Washington D.C., District of Columbia and 1 other locations
- Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (Recruiting)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Sahaja Acharya, MD — SKCCC Johns Hopkins Medical Institution
- Study coordinator: Sahaja Acharya, MD
- Email: sachary7@jhmi.edu
- Phone: 4432877889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.