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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03990597
Other study ID # 2018-0980
Secondary ID NCI-2019-0270920
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date August 19, 2019
Est. completion date November 24, 2020

Study information

Verified date November 2020
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 24, 2020
Est. primary completion date November 24, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Placebo Administration
Applied topically
Questionnaire Administration
Ancillary studies
Drug:
Wound Dressing Material
Applied StrataXRT topically

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events 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. Up to 6 weeks
Primary StrataXRT as a preventative agent for radiation-associated dermatitis To estimate the efficacy of StrataXRT among pediatric patients. Up to 6 weeks
Secondary Dosing of StrataXRT Up to 6 weeks
Secondary Parent-reported symptom experience 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]). Up to 6 weeks
Secondary Compliance As documented in a study log by participants. Up to 6 weeks
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