Working… Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03139318
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : May 26, 2021
Information provided by (Responsible Party):
University of Arkansas

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 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
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Measurement of toxicities associated with GRID Radiotherapy [ Time Frame: An average of 12 months ]
    Collection of toxicities

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT03139318

Layout table for location contacts
Contact: Sandy Annis, BA 5016868274
Contact: Kacie Simpson 5016868274

Layout table for location information
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Jose Penagaricano, MD    501-686-7284   
Contact: Beth Scanlan    (501) 526-6245   
Sponsors and Collaborators
University of Arkansas
Layout table for investigator information
Principal Investigator: Jose Penagaricano, MD University of Arkansas
Layout table for additonal information
Responsible Party: University of Arkansas Identifier: NCT03139318    
Other Study ID Numbers: 205993
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: May 26, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Layout table for MeSH terms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type