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Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03139318
Recruitment Status : Terminated (Due to COVID-19 and the resulting administrative issues, it is not feasible to continue the study.)
First Posted : May 3, 2017
Results First Posted : July 12, 2022
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Description
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Brief Summary:
The primary objective of this study is to evaluate the toxicity profile of GRID therapy using dose levels of 10Gy, 15 Gy and 20Gy in pediatric osteosarcoma of the extremity.

Condition or disease Intervention/treatment Phase
Osteosarcoma in Children Radiation Toxicity Radiation: GRID radiotherapy Not Applicable

Detailed Description:
Subjects will receive GRID radiotherapy. GRID radiation therapy is considered a standard radiation therapy method however is not typically used in pediatric osteosarcoma patients. This protocol will evaluate whether or not the use of this therapy will provide benefit to this patient population.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
Actual Study Start Date : July 25, 2017
Actual Primary Completion Date : August 29, 2018
Actual Study Completion Date : August 29, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GRID Radiotherapy
Patients will be treated with GRID Radiotherapy
 Radiation: GRID radiotherapy
Patients will be treated with GRID radiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Toxicities Associated With GRID Radiotherapy [ Time Frame: An average of 12 months ]
    The study endpoint is dose-limiting toxicity (DLT), which is defined as a treatment-related AE of Grade 3 or higher.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of cytological or histological documentation of non-metastatic extremity osteosarcoma.
  • 5-21 years of age.
  • Subject is eligible for routine chemotherapy and routine surgery for the treatment of non-metastatic extremity osteosarcoma
  • Informed consent is obtained

Exclusion Criteria:

  • Females with a positive urine pregnancy test.
  • Unable to comply with study procedures
Contacts and Locations
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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): NCT03139318


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Leslie Harrell, MD University of Arkansas
  Study Documents (Full-Text)

Documents provided by University of Arkansas:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] November 9, 2020

More Information
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03139318    
Other Study ID Numbers: 205993
First Posted: May 3, 2017    Key Record Dates
Results First Posted: July 12, 2022
Last Update Posted: July 20, 2022
Last Verified: June 2022
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Sarcoma