Proton Therapy for Craniopharyngioma

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

112 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Proton Therapy for Craniopharyngioma?

Research shows that proton therapy, including intensity-modulated proton therapy (IMPT), can reduce the dose of radiation to healthy brain areas compared to traditional radiation methods, potentially lowering the risk of long-term side effects in children with craniopharyngioma. ^{1 2 3 4 5}

Is proton therapy safe for treating craniopharyngioma in children?

Proton therapy, including various forms like intensity-modulated proton therapy (IMPT), is generally considered safe for treating craniopharyngioma in children, with studies showing it can reduce radiation exposure to healthy brain areas compared to other methods. However, there are uncertainties in how the therapy affects critical structures like the brainstem, so careful monitoring and further research are recommended. ^{1 2 3 4 6}

How is proton therapy different from other treatments for craniopharyngioma?

Proton therapy is unique because it uses a precise form of radiation that targets the tumor while minimizing damage to surrounding healthy tissues, which is especially important for craniopharyngiomas located near critical brain structures. This approach reduces the risk of long-term side effects compared to traditional radiation therapies. ^{1 2 3 5 7}

What is the purpose of this trial?

The goal of this study is to determine the feasibility and safety of treating patients with a brain tumor known as craniopharyngioma with 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). Irradiated patients will undergo a series of evaluations designed to evaluate the effects of proton therapy. Similar evaluations will be performed on patients treated with radical surgery. Proton therapy will include 30 treatment fractions administered 5 days per week. Weekly imaging will be a requirement to monitor for cyst expansion and target volume deformation.

Research Team

Thomas Merchant

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Dosimetric comparison of three-dimensional conformal proton radiotherapy, intensity-modulated proton therapy, and intensity-modulated radiotherapy for treatment of pediatric craniopharyngiomas. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Proton beam therapy versus conformal photon radiation therapy for childhood craniopharyngioma: multi-institutional analysis of outcomes, cyst dynamics, and toxicity. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Proton Therapy for Craniopharyngioma - An Early Report from a Single European Centre. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A dosimetric comparison of intensity-modulated proton therapy optimization techniques for pediatric craniopharyngiomas: a clinical case study. [2013]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Outcome after proton beam therapy versus photon-based radiation therapy in childhood-onset craniopharyngioma patients-results of KRANIOPHARYNGEOM 2007. [2023]

6. England pubmed.ncbi.nlm.nih.gov

The impact of proton LET/RBE modeling and robustness analysis on base-of-skull and pediatric craniopharyngioma proton plans relative to VMAT. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Proton Radiation Therapy for Pediatric Craniopharyngioma. [2021]