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

NCT03990597 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-10-09

No results posted yet for this study

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.

Conditions

  • Central Nervous System Sarcoma
  • Ependymoma
  • Glioma
  • Malignant Intracranial Germ Cell Tumor
  • Medulloblastoma
  • Pineoblastoma
  • Primary Central Nervous System Neoplasm

Interventions

OTHER

Placebo Administration

Applied topically

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Wound Dressing Material

Applied StrataXRT topically

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Susan L McGovern · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-19
Primary Completion
2020-11-24
Completion
2020-11-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03990597 on ClinicalTrials.gov