TerminatedPhase 1 / Phase 2NCT02581384
Official study title

Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors

Study summary

This research study is studying stereotactic body radiotherapy (SBRT) as a possible treatment for lung relapse of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). SBRT is a form of targeted radiotherapy that can treat very small tumors using a few large doses.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedStereotactic Body Radiotherapy (SBRT)

The study team can explain what participation involves.

Who it may be forEwing Sarcoma · Rhabdomyosarcoma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 30, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Dana-Farber Cancer Institute

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Dana-Farber Cancer Institute
Interventions being studied
Radiation: Stereotactic Body Radiotherapy (SBRT)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Diagnosis of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid)
  • Age ≤ 21 years;
  • Must be capable of treatment without general anesthesia
  • Lesion size 8 mm - 3 cm
  • Subjects who have lesions within 2 cm of central structures, will be eligible on a case by-case basis
  • Pulmonary metastases found at relapse (does not have to be first relapse); no more than 3 lesions per hemi-thorax will be treated but other lesions in the lung may be present
  • Greater than 5 weeks from doxorubicin at the time of consent, with radiation to be initiated no less than 6 weeks from doxorubicin
  • Informed consent/assent
  • Life expectancy \>3 months
  • Pulmonary Function FEV1 ≥ 50% of predicted;
  • Concurrent immunotherapy is allowed
Reasons someone may not be able to joinExclusion criteria
  • Prior whole-lung or hemi-thorax irradiation of greater than 12 Gy received less than 6 months prior to consent (focal radiotherapy to the thorax is not an exclusion)
  • Lesion larger than 3 cm in diameter
  • Patients for whom surgery would be deemed appropriate rather than radiotherapy

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Boston Children's HospitalBoston, Massachusetts
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • Dana Farber Cancer InstituteBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 30, 2021. Always confirm current availability with the study team.

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