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

NCT07514819 | Not Yet Recruiting

• 1 other identifier: SJPROTON3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Solid Tumors; Rhabdomyosarcoma; Ewing Sarcoma; Osteosarcoma; Hodgkin Lymphoma; Bone Tumor; Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (3)

• Rate of Replanning Treatment

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

  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)

• 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

  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)

• 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

  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)

Study Arms (1)

Adaptive Proton Therapy With Systematic On Therapy Imaging

EXPERIMENTAL

All enrolled participants receive standard of care proton therapy combined with systematic on therapy imaging (CT and/or MRI) during treatment. Imaging is used to generate verification plans to assess dose delivery relative to the original plan. Adaptive replanning is implemented if predefined dosimetric thresholds are exceeded.

Radiation: Proton Therapy (Adaptive)

Interventions

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.

Adaptive Proton Therapy With Systematic On Therapy Imaging

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Rhabdomyosarcoma; Sarcoma, Ewing; Osteosarcoma; Hodgkin Disease; Bone Neoplasms; Sarcoma

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Ozgur Ates, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ozgur Ates, PhD

CONTACT

888-226-4343; referralinfo@stjude.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2031
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)