Proton Therapy for Craniopharyngioma

Not currently recruiting at 1 trial location

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Prior radiation, Intracystic P-32, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 30

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of proton therapy for treating craniopharyngioma, a type of brain tumor. Instead of removing the entire tumor surgically, this approach uses proton therapy, which delivers precise radiation beams, following a smaller surgery. The goal is to determine if this method can control the tumor effectively while reducing side effects. Suitable candidates have craniopharyngioma and have not undergone full tumor removal surgery. Participants will receive regular checks to monitor the treatment's impact on the tumor. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in treatment.

Will I have to stop taking my current medications?

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.

Is there any evidence suggesting that proton therapy and limited surgery are likely to be safe for treating craniopharyngioma?

Research has shown that proton therapy is a well-tolerated and effective treatment for craniopharyngioma, a type of brain tumor. Studies have found that this therapy controls the tumor effectively and has manageable side effects. One study suggested that proton therapy may lead to better survival rates and fewer side effects compared to traditional radiation treatments.

Other research indicates that proton therapy is particularly promising for children and teens with craniopharyngioma, providing strong tumor control with acceptable short-term and long-term side effects. Unlike standard X-ray radiation, proton therapy targets the tumor more precisely, which helps protect healthy brain tissue.

Overall, early findings suggest that proton therapy is a safe option for treating craniopharyngioma, focusing on reducing harmful side effects while effectively managing the tumor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about proton therapy for craniopharyngioma because it offers a targeted approach that minimizes damage to surrounding healthy brain tissue. Unlike traditional radiation therapy, which can affect a broader area, proton therapy uses precise beams of protons to deliver radiation directly to the tumor with less collateral damage. This precision is particularly important for craniopharyngioma, which is located near critical brain structures. Additionally, proton therapy is combined with limited surgery, which can reduce the need for more invasive procedures and potentially lower the risk of surgical complications. This combination aims to improve treatment outcomes and quality of life for patients.

What evidence suggests that proton therapy might be an effective treatment for craniopharyngioma?

Research has shown that proton therapy, one of the treatments in this trial, works well for treating craniopharyngioma, especially in children and teenagers. Studies have found that this treatment effectively controls the tumor. Proton therapy usually causes fewer side effects than traditional radiation methods. It also improves survival rates and reduces harmful effects. Overall, proton therapy is a promising option for managing craniopharyngioma, offering good control of the disease with minimal severe side effects. Participants in this trial will receive proton therapy combined with limited surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Thomas Merchant

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for individuals aged 0-21 years diagnosed with craniopharyngioma, confirmed through tissue samples or imaging. It's not open to pregnant females due to radiation risks, nor those who've had prior fractionated radiation therapy, intracystic P-32 treatment, bleomycin or radiosurgery.

Inclusion Criteria

I have been diagnosed with craniopharyngioma.

I was diagnosed with my condition before turning 22.

Exclusion Criteria

I have had treatment with P-32, bleomycin, or radiosurgery for a cyst.

Pregnant females are excluded due to the teratogenic or abortifacient effects of radiation.

I have had radiation therapy in parts before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Limited Surgery and Proton Therapy

Participants undergo limited surgery followed by proton therapy with a 5mm clinical target volume margin. Proton therapy includes 30 treatment fractions administered 5 days per week.

6 weeks

30 visits (in-person)

Observation

Participants who have had radical surgery or limited surgery prior to enrollment and have no evidence of tumor will be observed.

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluations for progression-free and overall survival.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Limited Surgery
• Proton Therapy

Trial Overview The study tests limited surgery followed by proton therapy on patients with craniopharyngioma who haven't undergone radical surgery. Proton therapy involves 30 sessions over six weeks with weekly imaging to monitor the brain tumor's response.

How Is the Trial Designed?

Group I: Craniopharyngioma Patients Experimental Treatment 4 Interventions

Craniopharyngioma patients will have limited surgery and a 5mm clinical target volume margin in combination with proton therapy. Proton therapy will be indicated for patients with diagnosed craniopharyngioma who are not treated with radical surgery (gross-total resection). Patients who have had radical surgery or limited surgery prior to enrollment on this study and have no evidence of tumor will be observed for 5 years. Participants receive \^1\^8F-fluorodeoxyglucose and \^1\^1C-methionine will be given to aid in tumor visualization.

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11566716/

Proton beam therapy for craniopharyngioma - PubMed Central PBT for craniopharyngioma, especially in children and adolescents, has shown impressive local control and acceptable acute and late toxicities.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814020302334

Pencil beam scanning proton therapy for the treatment of ... Surgery and proton therapy results in excellent disease control for pediatric craniopharyngioma. Severe acute toxicity is rare. Late toxicities from tumor ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12474669/

Efficacy and safety of proton therapy and photon therapy for ... Compared with photon therapy, proton therapy may be associated with improved survival outcomes and reduced incidence of toxic effects in CP ...

4. redjournal.org redjournal.org/article/S0360-3016(24)00432-2/fulltext

Outcome After Modern Proton Beam Therapy in Childhood ... The aim of this study was to analyze survival outcome and late toxicities after surgery and proton beam therapy (PBT) in childhood CPs. Methods and Materials.

5. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)00635-2/abstract

Robustness evaluation of pencil beam scanning proton ... Compared to conventional radiotherapy using X-rays, proton therapy, in principle, allows better conformity of the dose distribution to target volumes, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2331518023000252

Review Articles Craniopharyngioma and Proton Therapy Proton therapy is an effective and well-tolerated radiation therapy modality for patients with craniopharyngioma.

7. cureus.com cureus.com/articles/391357-therapeutic-outcomes-and-toxicity-mitigation-of-proton-beam-therapy-in-pediatric-neuro-oncology-a-systematic-review

Therapeutic Outcomes and Toxicity Mitigation of Proton ... Does the combination of limited surgery and PBRT improve progression-free survival, overall survival, and cognitive outcomes in pediatric and ...