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Ewing SarcomaPhase 1/2NCT02581384

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

A Phase 1/2 study testing Stereotactic Body Radiotherapy (SBRT) in people with Ewing Sarcoma and Rhabdomyosarcoma, run by Dana-Farber Cancer Institute at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages Up to 21 years
Conditions the study is for
Ewing Sarcoma, Rhabdomyosarcoma, Wilms Tumor
What is being tested?
Stereotactic Body Radiotherapy (SBRT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
3 sitesUnited States
Study dates
Jan 2017to Aug 2020
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

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.

Read the 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.

Being tested
Stereotactic Body Radiotherapy (SBRT)
Keywords
Ewing Sarcoma, Rhabdomyosarcoma, Wilms Tumor, Rhabdomyosarcoma of Mediastinum, Ewing's Sarcoma Metastatic, Ewing Family of Tumors, Ewing's Tumor Metastatic, Osteosarcoma, Metastatic, Osteosarcoma in Children, Rhabdoid Tumor, Lung Metastasis, Radiation for Children, SBRT for children, Stereotactic Body Radiotherapy, Pulmonary Metastasis, Lung Metastasis in Children, Pulmonary Metastasis in Children, Comfort Care, Palliative Care
Medical subject headings
Sarcoma, Ewing, Rhabdomyosarcoma, Wilms Tumor, Osteosarcoma, Sarcoma, Carcinoma, Renal Cell, Rhabdoid Tumor, Neuroectodermal Tumors, Primitive, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Body Radiotherapy (SBRT)Radiation

Study groups in NCT02581384
Study groupRoleWhat they receive
Cohort 1 Dose Level 1 [Phase I]ExperimentalParticipants 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.
Receives: Radiation: Stereotactic Body Radiotherapy (SBRT)
Cohort 1 Dose Level 2 [Phase I]ExperimentalParticipants with Wilms tumors or other primary renal tumors. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.
Receives: Radiation: Stereotactic Body Radiotherapy (SBRT)
Cohort 1 Dose Level 3 [Phase I]ExperimentalParticipants with Wilms tumors or other primary renal tumors. SBRT Dose Levels for each target lesion are three 12 Gy fractions for 36 Gy total.
Receives: Radiation: Stereotactic Body Radiotherapy (SBRT)
Cohort 2 Dose Level 2 [Phase I]ExperimentalParticipants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.
Receives: Radiation: Stereotactic Body Radiotherapy (SBRT)
Cohort 2 Dose Level 3 [Phase I]ExperimentalParticipants with Ewing sarcoma or rhabdomyosarcoma.SBRT Dose Levels for each target lesion are three 12 Gy fractions for 36 Gy total.
Receives: Radiation: Stereotactic Body Radiotherapy (SBRT)
Cohort 2 Dose Level 2 [Phase II]ExperimentalParticipants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.
Receives: Radiation: Stereotactic Body Radiotherapy (SBRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose Limiting Toxicity [Phase I]

    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.

    Measured: Up to 6 months

  2. Overall Response Rate [Phase II]

    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.

    Measured: 6 weeks

Secondary outcomes (4)

  1. Complete Response Rate [Phase II]

    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.

    Measured: 6 weeks

  2. 2 Year Local Control Rate [Phase II]

    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.

    Measured: 24 Months

  3. Percentage of Participants With 2-Year Failure-Free Survival [Phase II]

    Rate of distant lung failure-free survival defined lung failure or death from any cause at two years. Lung failure defined using established methods.

    Measured: 24 months

  4. Number of Participants With Grade 3 or Higher Adverse Events [Phase I and II]

    Grade 3 or higher adverse events as defined by controlled terminology criteria for adverse events (CTCAE) version 4.

    Measured: Up to 6 months post-treatment (6 months and 2 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2015 (estimated)
  2. Study startJan 2017
  3. Primary completionAug 2020
  4. Study completionAug 2020

Why it stopped: The study closed primarily due to weak accrual, as well as study design limitations.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02581384
Sponsor's protocol ID
15-278
Status last verified
Apr 2021
First submitted
19 Oct 2015
Last updated
30 Apr 2021
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Liu KX, Chen YH, Kozono D, Mak RH, Boyle PJ, Janeway KA, Mullen EA, Marcus KJ. Phase I/II Study of Stereotactic Body Radiation Therapy for Pulmonary Metastases in Pediatric Patients. Adv Radiat Oncol. 2020 Sep 23;5(6):1267-1273. doi: 10.1016/j.adro.2020.09.004. eCollection 2020 Nov-Dec.

    PubMed 33305087

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Stereotactic Body Radiotherapy (SBRT) in people with Ewing Sarcoma and Rhabdomyosarcoma, run by Dana-Farber Cancer Institute at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose Limiting Toxicity [Phase I] (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02581384, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.

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