Adaptive Proton Therapy for Pediatric Solid Tumors and Hodgkin's Lymphoma

This study is looking at how to make proton therapy (a type of radiation treatment that targets tumors precisely) even better for children with solid tumors like Rhabdomyosarcoma, Ewing sarcoma, Osteosarcoma, other sarcomas and carcinomas, or Hodgkin's lymphoma. During treatment, a child's body and tumor can change, which might make the original radiation plan less accurate. This study uses regular low-dose imaging (CT scans weekly or every other week, and MRI if needed) to check for these changes. If the tumor coverage drops by more than 5% or if healthy tissues get too much radiation, the treatment plan will be updated. The goal is to see how often these plans need to be adjusted and if this adaptive approach improves tumor control and reduces side effects. About 100 patients at St. Jude Children's Research Hospital will participate. The study's status is unclear.

Study design
This is a single-arm study involving about 100 pediatric patients. It is an interventional study, but the phase is not specified.
What's involved
You would receive additional CT scans, and MRI when needed, during your proton therapy, either weekly or every other week for the duration of your treatment (about 6 to 10 weeks).
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured during on-therapy imaging, which occurs for the duration of your treatment course (roughly 6 to 10 weeks).

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NCT07514819

Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma

Recruiting
NAAll AgesInterventional
St. Jude Children's Research Hospital
~100 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Proton Therapy (Adaptive)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Replanning Treatment
Measured over Captured during on-therapy imaging (occurring either weekly or bi-weekly) for the duration of the patient's treatment course (varies depending on individual cases, anywhere from roughly 6 weeks to 10 weeks)
+2 more outcomes measured
Pediatric Solid Tumors
Rhabdomyosarcoma
Ewing Sarcoma
Osteosarcoma
Hodgkin Lymphoma
Bone Tumor
Soft Tissue Sarcoma
1 sites across 1 states
Tennessee1
  • Ozgur Ates, PhD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

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Eligibility criteria

Inclusion

Participants diagnosed with solid tumors, including Rhabdomyosarcoma, Osteosarcoma, Ewing sarcoma, other sarcomas and carcinomas or also Hodgkin's lymphoma.
Participants who receive proton radiation therapy at St. Jude Children's Research Hospital.
Research participant or legal guardian/representative gives written informed consent.

Exclusion

Participants who are not diagnosed with solid tumors or Hodgkin's lymphoma.
Participants who are diagnosed with Wilm's tumor or neuroblastoma
Participants who do not undergo proton therapy.
Participants who are prescribed equal or less than 5 fractions of proton therapy.
Participants with severe comorbid conditions that may impact imaging feasibility.
Inability to obtain written consent from research participant or legal guardian/representative.
Females of child-bearing potential cannot be pregnant or breast-feeding. Female participants \>10 years of age or post-menarchal must have a negative serum or urine pregnancy test
  • Rate of Replanning TreatmentCaptured during on-therapy imaging (occurring either weekly or bi-weekly) for the duration of the patient's treatment course (varies depending on individual cases, anywhere from roughly 6 weeks to 10 weeks)

    Descriptive statistics for number of cases replanned during treatment course will be reported

  • Tumor Control Probability (TCP) and Normal Tissue Complication Probability (NTCP)Captured during on-therapy imaging (occurring either weekly or bi-weekly) for the duration of the patient's treatment course (varies depending on individual cases, anywhere from roughly 6 weeks to 10 weeks)

    Descriptive statistics for V95% (tumor coverage) and OAR (organs-at-risk) will be reported, as well as signed-rank tests to evaluate adaptive planning effectiveness

  • Correlation between tissue discrepancies and changes in proton range, and deviations from intended plan qualityCaptured during on-therapy imaging (occurring either weekly or bi-weekly) for the duration of the patient's treatment course (varies depending on individual cases, anywhere from roughly 6 weeks to 10 weeks)

    Spearman correlation will be reported, assessing the associations between factors