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

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ClinicalTrials.gov Identifier: NCT03139318
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : September 8, 2017
Sponsor:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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 2019
Estimated Study Completion Date : June 2020

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



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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

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


Contacts
Contact: Sandy Annis, BA 5016868274 amannis@uams.edu
Contact: Kacie Simpson 5016868274 KLSimpson@uams.edu

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Jose Penagaricano, MD    501-686-7284    PenagaricanoJoseA@uams.edu   
Contact: Matthew R Kovak, MS    5016868274 ext 8714    mrkovak@uams.edu   
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Jose Penagaricano, MD University of Arkansas

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03139318     History of Changes
Other Study ID Numbers: 205993
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma