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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSt. Jude Children's Research Hospital

About this trial

Pediatric patients receiving proton therapy for solid tumors or Hodgkin's lymphoma may experience anatomical changes during treatment that can affect proton therapy accuracy. This prospective single-arm study uses regular low-dose imaging to monitor these changes and adjust treatment plans as needed. Participants will receive weekly or every-other-week CT scans, with MRI when appropriate, to assess whether the original plan remains accurate. Treatment plans will be updated if tumor coverage decreases by more than 5% or if radiation dose to normal tissues increases by more than 10%; otherwise, the original plan will continue. The study aims to determine how often plan adjustments are needed and to identify which disease sites are most likely to experience significant anatomical changes during treatment.

Primary Objective:

* Define the frequency of replanning necessary to ensure tumor coverage never falls below 95% (or 5% drop) of the prescribed daily dose in participants with intact (gross) tumors to keep the tumor control optimal throughout the multi-week treatment regimen. * Define the frequency of replanning necessary to ensure organs-at-risk (critical organs) do not deviate by more than 10% of the initially approved dose constraints to keep the normal tissue complication minimal throughout the multi-week treatment regimen.

Secondary Objectives

* Establish a cone beam CT (CBCT)-based framework for quantifying body surface changes throughout the treatment course. This goal will be achieved by developing a novel algorithm that detects and tracks external anatomical variations longitudinally, without requiring CBCT image enhancement, enabling precise assessment of daily participant setup consistency and anatomical stability. * Overcome daily CBCT quality limitations by generating synthetic CT images that accurately represent daily anatomy and support proton dose recalculation or verification planning. This goal will be achieved by developing a hybrid pipeline that integrates deep learning models with the deformable image registration algorithm, trained and validated on disease site-specific data. This will enable precise dose mapping and tissue density estimation, directly supporting adaptive planning decisions without the need of diagnostic- quality CT images.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Proton Therapy (Adaptive)

    Radiation

    Proton beam radiation therapy delivered per standard disease or site specific protocols, with additional on therapy CT and/or MRI imaging performed weekly or bi weekly during treatment. Verification planning is conducted using updated imaging, and treatment plans are adaptively replanned when tumor coverage decreases by ≥5% or organ at risk dose increases by ≥10% compared with the originally approved plan. Total dose, fractionation, and treatment schedule follow standard of care and are determined by the treating physician.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Adaptive Proton Therapy With Systematic On Therapy ImagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of Replanning Treatment

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

Time frame
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

Tumor Control Probability (TCP) and Normal Tissue Complication Probability (NTCP)

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

Time frame
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)
3

Correlation between tissue discrepancies and changes in proton range, and deviations from intended plan quality

Spearman correlation will be reported, assessing the associations between factors

Time frame
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)

Secondary outcomes

Other outcomes

Sponsors and contacts

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