Proton Therapy for Craniopharyngioma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for craniopharyngioma, a rare brain tumor, using intensity-modulated proton therapy. This advanced radiation therapy aims to treat the tumor effectively while reducing side effects compared to traditional radiation. Participants will either undergo surgery followed by proton therapy if needed or receive proton therapy directly if surgery isn't possible. The trial seeks children and young adults diagnosed with craniopharyngioma who have not had previous radiation treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to benefit from cutting-edge 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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that intensity-modulated proton therapy is generally safe and well-tolerated for treating craniopharyngioma, especially in children and teenagers. Studies have found that it effectively controls the tumor with manageable short-term and long-term side effects. Compared to traditional photon therapy, proton therapy might improve survival rates and cause fewer harmful effects. However, some side effects can appear years after treatment. Considering these potential risks and benefits is important when evaluating participation in a clinical trial.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about proton therapy for craniopharyngioma because it offers a more precise way to target tumors. Unlike traditional radiation, which can affect surrounding healthy tissue, intensity-modulated proton therapy delivers radiation directly to the tumor site, minimizing damage to nearby areas. This precision is especially important in brain tumors, where sparing healthy tissue can lead to better outcomes and fewer side effects. Additionally, for patients who cannot have surgery, proton therapy provides a non-invasive alternative that still effectively targets the tumor.
What evidence suggests that intensity-modulated proton therapy could be an effective treatment for craniopharyngioma?
Research has shown that proton therapy, particularly the advanced form known as intensity-modulated proton therapy (IMPT), effectively treats craniopharyngioma, a type of brain tumor. In this trial, participants whose tumors cannot be surgically removed will undergo 6 weeks of proton therapy. Studies have found that this method effectively controls the tumor and causes fewer side effects than traditional x-ray radiation. IMPT is also linked to better survival rates and fewer harmful effects. Patients generally tolerate it well, making it a promising treatment option for this condition.12367
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 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo surgery to remove the tumor if eligible. If the entire tumor is not removed, they proceed to proton therapy.
Proton Therapy
Participants receive 6 weeks of intensity-modulated proton therapy if the tumor is not completely resected.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with outcome data collected for comparison to other participant groups.
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Active Control
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.
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:
- Head and neck cancers
- Squamous cell carcinoma
- Nasopharyngeal cancer
- Oropharyngeal cancer
- Thyroid cancer
- Salivary gland cancer
- Head and neck cancers
- Squamous cell carcinoma
- Nasopharyngeal cancer
- Oropharyngeal cancer
- Thyroid cancer
- Salivary gland cancer
- Head and neck cancers
- Squamous cell carcinoma
- Nasopharyngeal cancer
- Oropharyngeal cancer
- Thyroid cancer
- Salivary gland cancer
- Head and neck cancers
- Squamous cell carcinoma
- Nasopharyngeal cancer
- Oropharyngeal cancer
- Thyroid cancer
- Salivary gland cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Jude Children's Research Hospital
Lead Sponsor
Published Research Related to This Trial
Citations
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.
Pencil beam scanning proton therapy for the treatment of ...
Surgery and proton therapy results in excellent disease control for pediatric craniopharyngioma. ... Intensity Modulated Proton Therapy (IMPT). 2021, ...
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 ...
Review Articles Craniopharyngioma and Proton Therapy
Proton therapy is an effective and well-tolerated radiation therapy modality for patients with craniopharyngioma.
Outcome after proton beam therapy versus photon-based ...
Proton beam therapy (PBT) is being increas16ingly used to treat residual craniopharyngioma (CP) after hypothalamus-sparing surgery.
Therapeutic Outcomes and Toxicity Mitigation of Proton ...
Imaging Changes in Pediatric Intracranial Ependymoma Patients Treated With Proton Beam Radiation Therapy Compared to Intensity Modulated ...
Proton Therapy Research Portfolio
A comprehensive look at proton therapy for prostate cancer: The physics, the history, more than 30 years of data and the current research.
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