Proton Radiation Therapy Registry

Cancer, Therapy-Related Clinical Trial

Official title:

Proton Radiation Therapy Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04376229
• Other study ID #: J2008
• Secondary ID: IRB00228501
• Status: Recruiting
• Start date: April 7, 2020
• Est. completion date: December 2040

Study information

• Verified date: May 2023
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Akila Viswanathan, MD
• Phone: 410-502-1421
• Email: anv[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The Johns Hopkins Proton Therapy center is establishing a registry to capture the full 3D radiation dosimetry delivered to the patient, baseline clinical data, and disease, toxicity and quality of life outcomes. The goal is to have all patients treated at the proton center to be included in the registry to enable future comparisons of treatment outcomes to assist in understanding which patients can benefit from the use of protons.

Description:

Proton based radiation therapy has considerable dosimetric advantages over the standard photon based radiation therapy, with a significantly higher cost. The clinical advantages, however, may not be realized for all patient populations, even with the improved dose distributions. Establishing the clinical efficacy of proton therapy requires years of experience treating patients. The goal is to accelerate the knowledge gain through the use of the registry that allows for detailed information to be captured and is inclusive of every patient treated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2040
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• All patients treated at the proton center.

Exclusion Criteria:

• Any other than what is supplied in the inclusion criteria

Related Conditions & MeSH terms

• Cancer, Therapy-Related
• Neoplasms, Second Primary

Intervention

Other:
• Registry
Registry of cancer patients who receive proton radiation therapy

Locations

Country	Name	City	State
United States	Bayview Hospital	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Sibley Memorial Hospital	Washington	District of Columbia
United States	Suburban Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Research registry of cancer patients receiving proton radiation therapy	This is a clinic based registry of cancer patients' data from participants to be collected over 15 years. The registry will be populated with 3D anatomy and radiation dosimetry from the RayStation treatment planning system used to plan all proton therapy patients. Clinical data will be extracted electronically from the MOSAIQ oncology information system used to manage the radiation therapy treatments. Structured clinical assessments will be routinely captured in the clinical workflow during patient encounters. Patient reported outcomes will be captured with iPad's using the OncoBrowser tools developed in radiotherapy that also interface with MOSAIQ.	15 years