Targeted radiation therapy for young patients with metastatic sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sibley Memorial Hospital
  Washington D.C., District of Columbia, United States Recruiting
• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting
• University of Minnesota
  Minneapolis, Minnesota, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.