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OpenTrials
Completed

NCT Number: NCT06310655

Online Proton Adaptive Radiotherapy

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Proton SBRT

Radiation

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

Primary outcomes

  1. Feasibility of Online Proton Adaptive Radiotherapy

    Time frame: Through end of treatment (up to 2 weeks)

    Feasibility will be defined as successful completion of the online adaptive proton radiotherapy workflow in at least 70% of planned adaptive fractions.

Secondary outcomes

  1. Safety of Online Proton Adaptive Radiotherapy as Measured by the Number of Grade 2 and Higher Radiation-related Toxicities

    Time frame: From start of treatment through 3 months

    Adverse events (AEs) are graded per CTCAE v5.0.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • The Foundation for Barnes-Jewish Hospital

Registry information

Official study title

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

Acronym: PARTy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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