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

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ClinicalTrials.gov Identifier: NCT02581384
Recruitment Status : Recruiting
First Posted : October 21, 2015
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Karen J Marcus, MD FACR, Boston Children’s Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Ewing Sarcoma Rhabdomyosarcoma Wilms Tumor Osteosarcoma Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Nos Renal Tumor Rhabdoid Tumor Clear Cell Renal Cell Carcinoma Sarcoma Sarcoma, Ewing Soft Tissue Sarcoma Radiation: Stereotactic Body Radiotherapy (SBRT) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors
Study Start Date : May 2016
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2029


Arm Intervention/treatment
Experimental: Stereotactic Body Radiotherapy

Stereotactic Body Radiotherapy (SBRT)

  • Different dose levels will be used in the two cohorts.
  • Ewing sarcoma, rhabdomyosarcoma, and others with non-renal tumor patients begin at a pre-determined dose per protocol.
  • Wilms tumors or other primary renal tumors renal tumor patients begin at pre-determined dose per protocol.

    • The two cohorts will be enrolling patients independently and simultaneously.
Radiation: Stereotactic Body Radiotherapy (SBRT)



Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: 6 Months ]
    The Phase I portion will evaluate the toxicity profile of each dose level and determine whether a given dose level could move forward to the Phase II portion

  2. Overall Response [ Time Frame: 6 weeks ]
    Response after 6 weeks will be assessed


Secondary Outcome Measures :
  1. Best Overall Response [ Time Frame: 2 years ]
    The Kaplan and Meier method will be used to measure relapse time elsewhere in the lung. All patients who takes part in the treatment will be monitored for toxicity, and the percent of patients with various toxicities will be calculated for each dose level.



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581384


Contacts
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Contact: Karen J Marcus, MD 617-732-8783 karen_marcus@dfci.harvard.edu
Contact: Cierra W Zaslowe-Dude, BA 6175828987 czaslowe-dude@bwh.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Karen Marcus, MD    617-355-8399      
Principal Investigator: Karen J Marcus, MD         
Sub-Investigator: Katherine Janeway, MD         
Sub-Investigator: Elizabeth Mullen, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Karen Marcus, MD    617-355-8399      
Principal Investigator: Karen Marcus, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Karen J Marcus, MD    617-355-8399      
Principal Investigator: Karen J Marcus, MD         
Sub-Investigator: Katherine Janeway, MD         
Sub-Investigator: Elizabeth Mullen, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Karen Marcus, MD Dana-Farber Cancer Institute

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Responsible Party: Karen J Marcus, MD FACR, Karen J Marcus, M.D., Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02581384     History of Changes
Other Study ID Numbers: 15-278
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Karen J Marcus, MD FACR, Boston Children’s Hospital:
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
Additional relevant MeSH terms:
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Neoplasm Metastasis
Sarcoma
Carcinoma, Renal Cell
Osteosarcoma
Rhabdomyosarcoma
Sarcoma, Ewing
Wilms Tumor
Rhabdoid Tumor
Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn