Recruiting

Targeted Radiation

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT06796543

Conditions

Metastatic Sarcoma

Radiation Therapy Patient

Ewing Sarcoma

Rhabdomyosarcoma

Eligibility Criteria

Sex: All

Age: 0 - 39

Healthy Volunteers: Not accepted

Interventions

Consolidative radiation therapy (cRT)

Study Details

Brief 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.

Conditions

Metastatic Sarcoma

Radiation Therapy Patient

Ewing Sarcoma

Rhabdomyosarcoma

Study ID

NCT06796543

Start date

Mar 25, 2025

Status verified date

Jul, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 39

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Consolidative radiation therapy (cRT)

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.

no intervention: standard of care (SOC)

Patients in Stratum B will undergo standard of care (SOC) second line systemic therapy with radiation to at least one disease site.

Interventions

Consolidative radiation therapy (cRT)

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.

Primary outcome measure

  • Event free survival [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Sahaja Acharya, MD

4432877889sachary7@jhmi.edu

Colette Youstra, MSPH

2029192533cyoustr5@jh.edu

Locations

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Sahaja Acharya, MD

443-287-7889sachary7@jhmi.edu

Colette Youstra, MSPH

2029192533cyoustr5@jh.edu

Principal Investigator:

Sahaja Acharya, MD

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Sahaja Acharya, MD

443-287-7889sachary7@jhmi.edu

Colette Youstra, MSPH

2029192533cyoustr5@jh.edu

Principal Investigator:

Sahaja Acharya, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Leslie Chang, MD

612-273-6014lechang@umn.edu

Lydia Golden, MPH

612-301-7797golde406@umn.edu

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Pediatric
  • Metastatic Sarcoma
  • Ewing sarcoma
  • Rhabdomyosarcoma
  • Brain tumor
  • Longitudinal
  • Radiation Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-07-13.