Daily online adaptive planning for proton radiation therapy
A Novel Pilot Study of Online Proton Adaptive RadioTherapY (PARTy) Utilizing Computed Tomography On Rails
This study is testing a new way to create and adjust radiation treatment plans on the same day for patients with solid tumors to see if it makes their proton therapy safer and more effective.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT06310655 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility of daily online adaptive planning for patients receiving proton radiation therapy for solid tumors. The approach involves generating a treatment plan on the day of treatment, assessing its effectiveness, and making necessary adjustments while the patient is on the treatment table. This method aims to address uncertainties in treatment delivery due to anatomical changes and improve the safety and efficacy of proton therapy. The study will gather data to inform a larger trial in the future.
Who should consider this trial
Good fit: Ideal candidates include adults with oligometastatic or primary solid tumors planned for proton stereotactic body radiation therapy (SBRT).
Not a fit: Patients with conditions that do not involve solid tumors or those who are not medically fit for proton SBRT may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the precision and effectiveness of proton radiation therapy for patients with solid tumors.
How similar studies have performed: While the concept of adaptive radiation therapy is gaining traction, this specific approach to online adaptive planning in proton therapy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Allen Mo, M.D., Ph.D. — Washington University School of Medicine
- Study coordinator: Allen Mo, M.D., Ph.D.
- Email: amo@wustl.edu
- Phone: 314-717-2320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.