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

April 5, 2021 updated by: Karen J Marcus, MD FACR, Dana-Farber Cancer Institute
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This research study is a Pilot Study, also known as a Phase I-II study, which means it is the first time investigators are examining this study intervention for patients with lung recurrence of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, nonrhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). This study tests the most appropriate dose, safety and efficacy of SBRT for the treatment of lung recurrence of these cancers in children. Standard radiotherapy is typically used to treat Ewing sarcoma and is used to treat lung recurrence. SBRT is being used to treat adults with small inoperable lung cancers; in such cases, SBRT has been shown to be effective and well-tolerated. SBRT is also used to treat bone metastases in adults and children.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion 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

Exclusion 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 Dose Level 1 [Phase I]
Participants with Wilms tumors or other primary renal tumors. Stereotactic Body Radiotherapy (SBRT) Dose Levels for each target lesion are three 8 Gy fractions for 24 Gy total.
Radiation: Stereotactic Body Radiotherapy (SBRT)
Experimental: Cohort 1 Dose Level 2 [Phase I]
Participants with Wilms tumors or other primary renal tumors. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.
Radiation: Stereotactic Body Radiotherapy (SBRT)
Experimental: Cohort 1 Dose Level 3 [Phase I]
Participants with Wilms tumors or other primary renal tumors. SBRT Dose Levels for each target lesion are three 12 Gy fractions for 36 Gy total.
Radiation: Stereotactic Body Radiotherapy (SBRT)
Experimental: Cohort 2 Dose Level 2 [Phase I]
Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.
Radiation: Stereotactic Body Radiotherapy (SBRT)
Experimental: Cohort 2 Dose Level 3 [Phase I]
Participants with Ewing sarcoma or rhabdomyosarcoma.SBRT Dose Levels for each target lesion are three 12 Gy fractions for 36 Gy total.
Radiation: Stereotactic Body Radiotherapy (SBRT)
Experimental: Cohort 2 Dose Level 2 [Phase II]
Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.
Radiation: Stereotactic Body Radiotherapy (SBRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Dose Limiting Toxicity [Phase I]
Time Frame: Up to 6 months

Dose Limiting Toxicities (DLT's) are toxicities experienced from start of therapy to 6 month. DLT's are assessed on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.

DLTs are defined as follows:

Grade 2 or higher toxicities:

  • Myelitis
  • Esophageal fistula, perforation, hemorrhage

Grade 3 or higher toxicities considered to be a direct result of therapy:

  • Pneumonitis
  • Pericarditis, pericardial effusion
  • Esophageal necrosis, stenosis, ulcer
  • Dyspnea

Grade 4 toxicities:

  • Esophagitis
  • Pericardial tamponade
  • Pulmonary toxicity excluding infectious pneumonia
  • Skin toxicity
  • Hemoptysis/pulmonary hemorrhage

Grade 5 toxicities, including:

  • Pulmonary toxicity including pneumonitis
  • Excluding infectious pneumonia

Three participants will enter the study in each cohort. If 0/3 patients experiences a DLT, this dose level will move forward to the Phase II and more participants will be enrolled.
Up to 6 months
Overall Response Rate [Phase II]
Time Frame: 6 weeks
Percentage of participants with response after 6 weeks. Response on treatment was considered to be Complete Response (CR) and Partial Response (PR) measured according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. For target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate [Phase II]
Time Frame: 6 weeks
Percentage of pulmonary lesions of participants with response after 6 weeks. Response on treatment was considered to be Complete Response (CR) measured according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. For target lesions, CR is complete disappearance of all target lesions.
6 weeks
2 Year Local Control Rate [Phase II]
Time Frame: 24 Months
Rate of local control (LC) of the index lesion after lung SBRT at 2 years. LC is defined as the absence of tumor progression within 1 cm of the primary tumor site. LC is measured by established methods.
24 Months
Percentage of Participants With 2-Year Failure-Free Survival [Phase II]
Time Frame: 24 months
Rate of distant lung failure-free survival defined lung failure or death from any cause at two years. Lung failure defined using established methods.
24 months
Number of Participants With Grade 3 or Higher Adverse Events [Phase I and II]
Time Frame: Up to 6 months post-treatment (6 months and 2 weeks)
Grade 3 or higher adverse events as defined by controlled terminology criteria for adverse events (CTCAE) version 4.
Up to 6 months post-treatment (6 months and 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Investigators

  • Principal Investigator: Karen Marcus, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (Estimate)

October 21, 2015

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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