Online Proton Adaptive Radiotherapy

Solid Tumor Clinical Trial

— PARTy  

Official title:

A Novel Pilot Study of Online Proton Adaptive RadioTherapY (PARTy) Utilizing Computed Tomography On Rails

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06310655
• Other study ID #: 202403078
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: Allen Mo, M.D., Ph.D.
• Phone: 314-717-2320
• Email: amo[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study evaluating the feasibility of daily online adaptive planning for patients undergoing proton radiation therapy. Patients undergoing proton radiation therapy normally undergo extensive pre-planning for their treatment. However, accounting for uncertainties in treatment delivery remains a challenge for a variety of reasons, such as differences in patient anatomy from pre-planning to the day of treatment. Online adaptive planning is a process consisting of generating the original pre-plan on the patient on a treatment day, assessing the pre-plan's coverage and safety, and if changes are needed, the plan is changed in order to optimize the treatment while the patient is still on the treatment table. This study is assessing the feasibility and safety of this approach in order to gather data for a larger trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 31, 2025
• Est. primary completion date: May 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Oligometastatic or primary malignancy planned for proton SBRT. Disease site should be biopsy-proven primary disease of solid tumor histology with the exception of Hepatocellular carcinoma (HCC). HCC does not need to be biopsy proven if imaging and clinical findings are consistent with the diagnosis.
• Must be deemed medically fit for proton SBRT by the treating physician.
• Prior radiation therapy is allowed.
• At least 18 years of age.
• Karnofsky = 70%.
• Because radiation therapy is known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, or a male suspect he has fathered a child, s/he must inform the treating physician immediately.
• Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

• Histology of small cell carcinoma. Mixed histologies with a predominantly small cell component are also exclusionary.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Medical contraindication to proton therapy or any other condition that in the opinion of the treating radiation oncologist, renders the patient unfit for SBRT
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
• Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of study entry.

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Radiation:
• Proton SBRT
Patients will receive SBRT over 5 days, either every day or every other day, to a dose of 25-50 Gy.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	The Foundation for Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of online proton adaptive radiotherapy	Feasibility will be defined as successful completion of the online adaptive proton radiotherapy workflow in at least 70% of planned adaptive fractions.	Through end of treatment (up to 2 weeks)
Secondary	Safety of online proton adaptive radiotherapy as measured by the amount of grade 2 and higher radiation-related toxicities	Adverse events are graded per CTCAE v5.0.	from start of treatment through 3 months

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine