Establishing Evidence-Based Indications for Proton Therapy: An Overview of Current Clinical Trials

Area of Science:

• Oncology
• Radiation Oncology
• Medical Physics

Background:

• Proton beam therapy (PBT) represents an advanced form of radiation oncology.
• Understanding the landscape of ongoing clinical trials is crucial for advancing PBT research.

Purpose of the Study:

• To comprehensively review and assess current proton beam therapy (PBT) clinical trials.
• To identify significant gaps in the PBT research portfolio.

Main Methods:

• Searched clinicaltrials.gov and WHO ICTRP for active PBT trials.
• Extracted data including disease site, patient enrollment, study type, and funding.

Main Results:

• Identified 122 active PBT trials targeting over 42,000 patients globally.
• Gastrointestinal, central nervous system, and prostate cancers are the most studied PBT indications.
• While most trials are interventional, observational studies enroll the majority of patients.

Conclusions:

• The PBT clinical trial landscape is growing, with a notable shift towards observational studies for patient accrual.
• Emphasis on randomized controlled trials is needed to evaluate comparative effectiveness and value against conventional therapies.
• Strategies for optimizing patient enrollment and retention in PBT trials are essential for future progress.