Proton Therapy for Craniopharyngioma

Overseen By Thomas E. Merchant, DO, PhD

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: Unknown

160 Participants Needed

Trial Summary

What is the purpose of this trial?

Craniopharyngioma is a rare brain tumor that affects both children and adults. It arises in a region of the brain near the pituitary gland, visual pathways, and central blood vessels. Patients often present with headache, loss of vision or delayed growth. In some instances they may present with imbalance of water and salts in the body. The treatment for craniopharyngioma may be radical surgery or a combination of surgery and radiation therapy. In some instances surgery is not required. If the tumor cannot be completely removed, radiation therapy may be required. In this study we will use the most advanced form of proton therapy which is called intensity-modulated proton therapy. This is a newer form of radiation therapy which has a number of advantages over older forms of proton therapy and conventional radiation therapy using x-rays. The main goal of this study is to learn if proton therapy will effectively treat patients with craniopharyngioma brain tumors and reduce side effects compared to more traditional forms of radiation therapy.

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 Intensity-Modulated Proton Therapy (IMPT) for craniopharyngioma?

Research shows that Intensity-Modulated Proton Therapy (IMPT) can reduce the dose of radiation to healthy brain areas compared to other radiation methods, which may help minimize long-term side effects in children with craniopharyngioma. Additionally, proton therapy has shown promising results in controlling disease and reducing toxicity in head and neck cancers, suggesting potential benefits for craniopharyngioma treatment. ^{1 2 3 4 5}

Is proton therapy safe for treating craniopharyngioma and other conditions?

Proton therapy, including intensity-modulated proton therapy (IMPT), is generally considered safe and has been shown to reduce exposure to healthy brain areas compared to traditional radiation methods. It is associated with fewer long-term side effects, especially in children, due to its ability to target tumors more precisely and spare normal tissues. ^{1 2 3 4 5}

How is Intensity-Modulated Proton Therapy (IMPT) different from other treatments for craniopharyngioma?

Intensity-Modulated Proton Therapy (IMPT) is unique because it uses precise proton beams to target tumors, reducing radiation exposure to healthy brain areas compared to traditional radiation therapies. This precision helps minimize long-term side effects, especially important in children whose brains are still developing. ^{1 2 3 6 7}

Research Team

Thomas Merchant

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for individuals aged 0-21 diagnosed with craniopharyngioma, a rare brain tumor. It's open to those who have not had complete surgical removal of the tumor or require observation after radical surgery. Pregnant females and patients previously treated with certain intracystic therapies or radiation are excluded.

Inclusion Criteria

I was diagnosed with my condition before turning 22.

My diagnosis of craniopharyngioma was confirmed through tests or surgery.

Exclusion Criteria

I have had treatment with P-32 or bleomycin directly into a cyst.

I have had radiation therapy in parts before.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo surgery to remove the tumor if eligible. If the entire tumor is not removed, they proceed to proton therapy.

Immediate

Proton Therapy

Participants receive 6 weeks of intensity-modulated proton therapy if the tumor is not completely resected.

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcome data collected for comparison to other participant groups.

5 years

Treatment Details

Interventions

• Intensity-Modulated Proton Therapy
• Surgery

Trial Overview The study tests intensity-modulated proton therapy (IMPT) for treating craniopharyngioma when surgery doesn't remove all of the tumor, aiming to see if IMPT can be more effective and cause fewer side effects than traditional radiation treatments.

Participant Groups

Group I: Tumor-Surgery Active Control 2 Interventions

Participants who are eligible to undergo surgery to remove the tumor will proceed to surgery. If all tumor is removed, they will be followed over 5 years for outcome comparison to the other participant groups. If the entire tumor is not removed by surgery, participants will receive 6 weeks of proton therapy. They will then be followed for 5 years to collect outcome data for comparison to the other participant groups.

Group II: Tumor-No Surgery Active Control 1 Intervention

Participants whose tumor cannot be resected through surgery will receive 6 weeks of proton therapy. They will then be followed over 5 years for outcome comparison to the other participant groups.

Intensity-Modulated Proton Therapy is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as IMPT for:

• Head and neck cancers
• Squamous cell carcinoma
• Nasopharyngeal cancer
• Oropharyngeal cancer
• Thyroid cancer
• Salivary gland cancer

Approved in European Union as IMPT for:

• Head and neck cancers
• Squamous cell carcinoma
• Nasopharyngeal cancer
• Oropharyngeal cancer
• Thyroid cancer
• Salivary gland cancer

Approved in Canada as IMPT for:

• Head and neck cancers
• Squamous cell carcinoma
• Nasopharyngeal cancer
• Oropharyngeal cancer
• Thyroid cancer
• Salivary gland cancer

Approved in Japan as IMPT for:

• Head and neck cancers
• Squamous cell carcinoma
• Nasopharyngeal cancer
• Oropharyngeal cancer
• Thyroid cancer
• Salivary gland cancer

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Findings from Research

Intensity Modulated Proton Therapy (IMPT) provided better target coverage for recurrent nasopharyngeal carcinoma (rNPC) compared to Intensity Modulated Radiotherapy (IMRT), achieving higher coverage percentages for both the gross tumor volume and clinical target volume.

While IMPT showed advantages in sparing critical neurological organs, it also resulted in higher maximum doses to the internal carotid artery and nasopharyngeal mucosa, indicating a need for careful monitoring of potential complications when using this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric comparison of intensity modulated radiotherapy and intensity modulated proton therapy in the treatment of recurrent nasopharyngeal carcinoma. Hung, HM., Chan, OCM., Mak, CH., et al.[2022]

Proton radiation therapy, particularly intensity-modulated proton therapy (IMPT), offers better dose localization compared to conventional photon radiation therapy, potentially reducing damage to surrounding healthy tissues in patients with head and neck and skull base tumors.

Initial clinical experiences suggest that IMPT may lead to fewer acute and long-term toxicities, and ongoing multi-institutional trials aim to further establish its effectiveness in treating these complex tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton radiation therapy for head and neck cancer. Chan, AW., Liebsch, NJ.[2018]

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

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

3. 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]

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

Dosimetric comparison of intensity modulated radiotherapy and intensity modulated proton therapy in the treatment of recurrent nasopharyngeal carcinoma. [2022]

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

Proton radiation therapy for head and neck cancer. [2018]

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

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

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

Proton Radiation Therapy for Pediatric Craniopharyngioma. [2021]