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StrataXRT in Preventing Radiation Dermatitis in Pediatric Patients Undergoing Radiation Therapy to the Brain or Spinal Cord

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ClinicalTrials.gov Identifier: NCT03990597
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : February 26, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date February 26, 2020
Actual Study Start Date  ICMJE August 19, 2019
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2019)
  • Incidence of adverse events [ Time Frame: Up to 6 weeks ]
    Graded per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety will be summarized with standard summary statistics by adverse event (AE), grade, relation, etc. using the CTCAE 5.0. All summaries will be calculated for each control and experimental forehead and ears.
  • StrataXRT as a preventative agent for radiation-associated dermatitis [ Time Frame: Up to 6 weeks ]
    To estimate the efficacy of StrataXRT among pediatric patients.
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Incidence of adverse events [ Time Frame: Up to 6 weeks ]
    Graded per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety will be summarized with standard summary statistics by adverse event (AE), grade, relation, etc. using the CTCAE 5.0. All summaries will calculated for each control and experimental forehead and ears.
  • StrataXRT as a preventative agent for radiation-associated dermatitis [ Time Frame: Up to 6 weeks ]
    Efficacy will be defined using the Radiation Therapy Oncology Group/European Organization for the Research and Treatment of Cancer (RTOG/EROTC) for both treatment and placebo groups. The RTOG/EROTC scales will be summarized by control and experimental ears at each time point (baseline, 5 weekly treatment visits, and at treatment completion visit [last day of radiation therapy]). Will estimate the treatment effect using generalized linear mixed models (GLMM). The primary efficacy measure will be the maximum grade observed from the Radiation Therapy Oncology Group (RTOG) throughout the six weeks of therapy. As grade 3 and 4 are clinically meaningful. The dependent variable will be observing a maximum grade of 3 and above (yes/no) and independent variable of treatment (StrataXRT vs. Placebo). The GLMM will allow random intercepts and treatment effects to take into account the within subject correlation and paired nature of the data (left ear vs. right ear treatment assignment).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2019)
  • Dosing of StrataXRT [ Time Frame: Up to 6 weeks ]
  • Parent-reported symptom experience [ Time Frame: Up to 6 weeks ]
    Will be measured by the Radiation-Induced Skin Reaction Assessment Scale (RISRAS). The RISRAS Radiation-Induced Skin Reaction Assessment Scale will be summarized by control and experimental ears at each time point (baseline, 5 weekly treatment visits, and at treatment completion visit [last day of radiation therapy]).
  • Compliance [ Time Frame: Up to 6 weeks ]
    As documented in a study log by participants.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Dosing of StrataXRT [ Time Frame: Up to 6 weeks ]
  • Parent-reported symptom experience [ Time Frame: Up to 6 weeks ]
    As measured by the Radiation-Induced Skin Reaction Assessment Scale (RISRAS). The RISRAS scale will be summarized by control and experimental ears at each time point (baseline, 5 weekly treatment visits, and at treatment completion visit [last day of radiation therapy]).
  • Compliance [ Time Frame: Up to 6 weeks ]
    As documented in a study log by participants.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE StrataXRT in Preventing Radiation Dermatitis in Pediatric Patients Undergoing Radiation Therapy to the Brain or Spinal Cord
Official Title  ICMJE A Pilot Study of StrataXRT, a Topical Silicone Barrier, to Prevent Auricular Radiation Dermatitis in Pediatric Patients Undergoing Proton Cerebrospinal Radiation Therapy
Brief Summary This phase I trial studies the side effects of a silicone topical wound dressing (StrataXRT) and to see how well it works in preventing radiation dermatitis (skin burns and side effects caused by radiation) in pediatric patients undergoing radiation therapy. StrataXRT may help prevent or decrease severe skin rash, pain, itching, skin peeling, and dry skin in pediatric patients undergoing radiation therapy to the brain or spinal cord.
Detailed Description

PRIMARY OBJECTIVES:

I. To estimate the safety (defined using the Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) of StrataXRT and placebo by assessing gel-associated toxicities among pediatric patients, aged 2-17 undergoing proton cerebrospinal irradiation (CSI) for central nervous system (CNS) tumors.

II. To estimate the efficacy of StrataXRT as a preventative agent for radiation-associated dermatitis among pediatric patients, aged 2-17 undergoing proton CSI for CNS tumors.

SECONDARY OBJECTIVES:

I. To explore the relationship between dosing and the efficacy of StrataXRT. II. To explore the relationship between the use of StrataXRT and parent-reported symptom experience, as measured by the Radiation-Induced Skin Reaction Assessment Scale (RISRAS).

III. To explore compliance with the application of treatment as documented in a study log by participants.

OUTLINE:

Beginning first day of CSI proton radiation therapy, caregivers apply StrataXRT gel to half of the patient's forehead and one ear and placebo to the other half of the forehead and the other ear twice daily (BID) until the last day of radiation therapy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Central Nervous System Sarcoma
  • Ependymoma
  • Glioma
  • Malignant Intracranial Germ Cell Tumor
  • Medulloblastoma
  • Pineoblastoma
  • Primary Central Nervous System Neoplasm
Intervention  ICMJE
  • Other: Placebo Administration
    Applied topically
    Other Names:
    • placebo
    • placebo therapy
    • PLCB
    • sham therapy
  • Other: Questionnaire Administration
    Ancillary studies
  • Drug: Wound Dressing Material
    Applied StrataXRT topically
    Other Name: Wound Dressing
Study Arms  ICMJE Experimental: Supportive care (StrataXRT, placebo)
Beginning first day of CSI proton radiation therapy, caregivers apply StrataXRT gel to half of the patient's forehead and one ear and placebo to the other half of the forehead and the other ear BID until the last day of radiation therapy.
Interventions:
  • Other: Placebo Administration
  • Other: Questionnaire Administration
  • Drug: Wound Dressing Material
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2020
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pediatric patients between the ages of 2 years old and 17 years old
  • Patients diagnosed with primary CNS tumors including medulloblastoma, pineoblastoma, ependymoma, intracranial germ cell, glioma or intracranial sarcoma who will be starting proton CSI
  • Patients planned to receive at least 20 Gy CSI at 1.8 - 2.0 Gy per fraction
  • Patients with an identified adult (aged 18 years or older caregiver)(familial or other) who consents to apply the StrataXRT and placebo twice a day for the duration of the study and complete the study instruments
  • Informed consent by parents or legal guardian; consent documents will be translated with non-English speaking participants

Exclusion Criteria:

  • Patients who have already started proton CSI treatment
  • Patients receiving > 10 fractions photon therapy
  • Patients with pre-existing dermal scarring, as determined by a clinical member of the study staff
  • Patients who only have a primary caregiver who is a minor (e.g. mother under the age of 18)
  • Patients planned to receive less than 20 Gy CSI at 1.8-2.0 Gy per fraction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Susan L McGovern 713-563-2300 slmcgove@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03990597
Other Study ID Numbers  ICMJE 2018-0980
NCI-2019-02709 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0980 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Susan L McGovern M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP