Central Nervous System SarcomaPhase 1NCT03990597
StrataXRT in Preventing Radiation Dermatitis in Pediatric Patients Undergoing Radiation Therapy to the Brain or Spinal Cord
A Phase 1 study testing Questionnaire Administration and Wound Dressing Material in people with Central Nervous System Sarcoma and Ependymoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Nervous System Sarcoma, Ependymoma, Glioma
- What is being tested?
- Questionnaire Administration and Wound Dressing Material
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2019to 24 Nov 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of StrataXRT, a Topical Silicone Barrier, to Prevent Auricular Radiation Dermatitis in Pediatric Patients Undergoing Proton Cerebrospinal Radiation Therapy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Central Nervous System Sarcoma, Ependymoma, Glioma, Malignant Intracranial Germ Cell Tumor, Medulloblastoma, Pineoblastoma
- Being tested
- Placebo Administration, Questionnaire Administration, Wound Dressing Material
- Medical subject headings
- Ependymoma, Glioma, Medulloblastoma, Pinealoma, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo AdministrationOther
Also called placebo, placebo therapy, PLCB, sham therapy
Applied topically
Questionnaire AdministrationOther
Ancillary studies
Wound Dressing MaterialDrug
Also called Wound Dressing
Applied StrataXRT topically
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (StrataXRT, placebo) | Experimental | 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. Receives: Other: Placebo Administration; Other: Questionnaire Administration; Drug: Wound Dressing Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 weeks
StrataXRT as a preventative agent for radiation-associated dermatitis
To estimate the efficacy of StrataXRT among pediatric patients.
Measured: Up to 6 weeks
Secondary outcomes (3)
Dosing of StrataXRT
Measured: Up to 6 weeks
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]).
Measured: Up to 6 weeks
Compliance
As documented in a study log by participants.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start19 Aug 2019
- Primary completion24 Nov 2020
- Study completion24 Nov 2020
Why it stopped: Per PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System SarcomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan L McGovern, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990597
- Sponsor's protocol ID
- 2018-0980
- Other IDs
- NCI-2019-02709, 2018-0980
- Status last verified
- Nov 2020
- First submitted
- 17 Jun 2019
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of StrataXRT, a Topical Silicone Barrier, to Prevent Auricular Radiation Dermatitis in Pediatric Patients Undergoing Proton Cerebrospinal Radiation Therapy
- ClinicalTrials.gov ID
- NCT03990597
- Acronym / sponsor ID
- 2018-0980
- Conditions
- Central Nervous System Sarcoma, Ependymoma, Glioma, Malignant Intracranial Germ Cell Tumor, Medulloblastoma, Pineoblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Per PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (StrataXRT, placebo) | Experimental | Other: Placebo Administration, Other: Questionnaire Administration, Drug: Wound Dressing MaterialBeginning 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. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo AdministrationAlso: placebo, placebo therapy, PLCB, sham therapyApplied topically | Other | Supportive care (StrataXRT, placebo) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (StrataXRT, placebo) |
| Wound Dressing MaterialAlso: Wound DressingApplied StrataXRT topically | Drug | Supportive care (StrataXRT, placebo) |
Primary outcome
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.
3 secondary outcomes
Dosing of StrataXRT
Time frame: Up to 6 weeks
Parent-reported symptom experience
Time frame: Up to 6 weeks
Compliance
Time frame: Up to 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan L McGovern principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Questionnaire Administration and Wound Dressing Material in people with Central Nervous System Sarcoma and Ependymoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.