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Trial record 8 of 250 for:    ewing sarcoma

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 : August 4, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This research study is studying stereotactic body radiotherapy (SBRT) as a possible treatment for lung relapse of Ewing Sarcoma, Rhabdomyosarcoma, or Wilms Tumor. 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 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, or Wilms Tumor. This study tests the most appropriate dose, safety and efficacy of SBRT for the treatment of lung recurrence of Wilms tumor, rhabdomyosarcoma, or Ewing sarcoma 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 Design

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 2019
Estimated Study Completion Date : February 2023


Arms and Interventions

Arm Intervention/treatment
Experimental: Stereotactic Body Radiotherapy

Stereotactic Body Radiotherapy (SBRT)

  • Different dose levels will be used in the two cohorts.
  • Ewing sarcoma or rhabdomyosarcoma with non-renal tumor patients beginning at pre determine dose per protocol.
  • Wilms tumors or other primary renal tumors renal tumor patients beginning at pre determine dose per protocol.

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


Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Ewing sarcoma, rhabdomyosarcoma or Wilms tumor or other primary renal tumor
  • Age 8.0 to age 18.99 years
  • Must be capable of treatment without general anesthesia
  • Lesion size 8 mm - 3 cm
  • Pulmonary metastases found at relapse (does not have to be first relapse); no more than 3 lesions per hemi-thorax
  • Greater than 5 weeks from doxorubicin at the time of consent, with radiation to be initiated no less than 6 weeks from doxorubicin
  • Greater than 3 weeks from intravenous chemotherapy except doxorubicin
  • Informed consent/assent
  • Life expectancy > 3 months
  • Pulmonary function FEV1 ≥ 50% of predicted
  • Females, minorities and other underrepresented populations that are at risk to develop Ewing sarcoma and the other included malignancies

Exclusion Criteria:

  • Prior whole-lung or hemi-thorax irradiation of greater than or equal to 12 Gy (focal radiotherapy to the thorax is not an exclusion)
  • Lesion larger than 3 cm in diameter
  • Diffuse multiple (> 3 per lung) metastases
  • Active or new metastatic disease outside of the lung
  • Lesions within 2 cm of central structures defined as:

Tumor within or touching the zone of the proximal bronchial tree, defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi).

Contacts and Locations

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
Contact: Karen J Marcus, MD 617-355-8399 kmarcus@partners.org

Locations
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
Principal Investigator: Karen Marcus, MD Dana-Farber Cancer Institute
More Information

Responsible Party: Karen J Marcus, MD, Karen J Marcus, M.D., Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT02581384     History of Changes
Other Study ID Numbers: 15-278
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Karen J Marcus, MD, Children's Hospital Boston:
Ewing Sarcoma
Rhabdomyosarcoma
Wilms Tumor

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Ewing
Rhabdomyosarcoma
Wilms Tumor
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Myosarcoma
Neoplasms, Muscle Tissue
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Complex and Mixed
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Kidney Diseases
Urologic Diseases
Genetic Diseases, Inborn