100 Participants NeededMy employer runs this trial

Adaptive Proton Therapy for Pediatric Cancer

Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: St. Jude Children's Research Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a method to make proton therapy, a type of radiation treatment, more precise for children with certain cancers, such as solid tumors or Hodgkin's lymphoma. Researchers aim to determine how often treatment plans need adjustment when changes occur in a child's body during therapy. The primary goal is to ensure the treatment remains effective and safe by using regular low-dose imaging, such as CT scans and MRIs. Children with solid tumors receiving proton therapy at St. Jude Children's Research Hospital may qualify for this trial. As an unphased trial, this study offers a unique opportunity to advance treatment precision and safety for future pediatric cancer patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this adaptive proton therapy protocol is safe for pediatric cancer patients?

Research has shown that proton beam therapy (PBT) is generally safe for children with cancer. Studies have found that it often leads to better outcomes and fewer long-term side effects compared to traditional radiation therapy. For example, PBT typically protects healthy tissues from excessive radiation, preserving normal brain functions and reducing the risk of developing other cancers later.

Regarding side effects, PBT is associated with a lower risk of heart problems compared to other radiation methods. This is particularly important for young patients who have many years ahead. Additionally, research indicates that survival rates for children receiving PBT are quite high. Specifically, one study showed a two-year overall survival rate of over 92%.

Overall, the treatment is considered well-tolerated and effective for childhood cancers, making it a promising option for reducing treatment-related harm while maintaining high survival rates.12345

Why are researchers excited about this trial?

Researchers are excited about adaptive proton therapy for pediatric cancer because it offers a more precise and personalized approach compared to traditional radiation therapy. Unlike conventional methods, this treatment uses systematic on-therapy imaging, such as CT or MRI, to monitor and adjust the radiation dose in real-time, ensuring it accurately targets the tumor while sparing surrounding healthy tissue. This adaptive replanning capability could potentially reduce side effects and improve outcomes for young cancer patients, making it a promising advancement in pediatric oncology.

What evidence suggests that adaptive proton therapy is effective for pediatric cancer?

Studies have shown that proton therapy effectively treats cancers in children, significantly improving survival rates. For example, one study found survival rates at one and two years to be 97.2% and 92.0%, respectively. Proton therapy targets tumors more precisely while protecting healthy tissues, reducing long-term side effects. Research indicates better disease control and survival compared to traditional radiation methods. Additionally, proton therapy results in lower radiation exposure to healthy brain areas, crucial for protecting growing bodies. Overall, proton therapy offers a promising treatment for children with solid tumors or Hodgkin's lymphoma.

In this trial, participants will receive adaptive proton therapy with systematic on-therapy imaging, using CT and/or MRI during treatment to ensure precise dose delivery and make necessary adjustments.12567

Who Is on the Research Team?

OA

Ozgur Ates, PhD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for children and teens with solid tumors (like rhabdomyosarcoma, osteosarcoma, Ewing sarcoma) or Hodgkin's lymphoma who are getting proton therapy at St. Jude. Participants must have consent from a parent/guardian and cannot be pregnant or breastfeeding.

Inclusion Criteria

Research participant or legal guardian/representative gives written informed consent
I have been diagnosed with a solid tumor or Hodgkin's lymphoma.
I am receiving proton radiation therapy at St. Jude Children's Research Hospital.

Exclusion Criteria

I have not received proton therapy.
I have been diagnosed with Wilm's tumor or neuroblastoma.
Participants with severe comorbid conditions that may impact imaging feasibility
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive proton therapy with systematic on-therapy imaging to monitor anatomical changes and adjust treatment plans as needed

6-10 weeks
Weekly or bi-weekly imaging visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Proton Therapy

Trial Overview

The study tests adaptive proton therapy using regular low-dose scans to check if treatment plans need adjusting during multi-week radiation. If big changes in tumor size or body shape occur, the plan is updated to keep treatment accurate and safe.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Adaptive Proton Therapy With Systematic On Therapy ImagingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials
451
Recruited
5,326,000+

Citations

Proton Beam Therapy Versus Photon Radiotherapy for ... - PMC

Eighteen studies (6 PBT, 12 XRT) were included. The 1‐ and 2‐year OS rates were 97.2% and 92.0% for PBT, and 89.1% and 81.3% for XRT.

Emerging Outcome Trends from Proton Therapy for ...

LGG and craniopharyngioma demonstrated high survival, showing over 95% OS up to ten years after treatment. Toxicity outcomes revealed common ...

Proton beam therapy for pediatric cancers

Proton beam therapy is transforming pediatric cancer care, with improved outcomes and reduced long-term side effects.

Therapeutic Outcomes and Toxicity Mitigation of Proton Beam ...

Across these studies, PBT was associated with higher rates of disease control and survival, lower radiation exposure to healthy brain structures ...

Outcome After Modern Proton Beam Therapy in Childhood ...

The estimated (±SE) 3-year overall survival, progression-free, and cystic failure-free survival rate after PBT were 98.2% (±1.7), 94.7% (±3.0), and 76.8% (±5.4) ...

Adaptive Proton Therapy for Pediatric Patients

This study examined whether offline adaptation using on-treatment magnetic resonance imaging (MRI) scan during proton therapy could improve plan quality for ...

Proton beam therapy in paediatric radiation oncology

This review explores the development of PBT, its dosimetric advantages over conventional x-ray-based radiotherapy, and the rationale behind its use in ...