Clinical trial NCT06310655: Online Proton Adaptive Radiotherapy
Official title: A Novel Pilot Study of Online Proton Adaptive RadioTherapY (PARTy) Utilizing Computed Tomography On Rails
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Tumor
Keywords: SBRT
proton radiotherapy
reirradiation
Adaptive radiation therapy
Online adaptive radiotherapy
online proton adaptive radiotherapy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Foundation for Barnes-Jewish Hospital
First posted: 2024-03-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will receive 5 fractions of proton radiotherapy for their cancer. At the time of each fraction, the initial pre-plan will be compared to the newly generated adapted plan, and the optimal treatment will be administered.
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Feasibility of online proton adaptive radiotherapy
timeFrame: Through end of treatment (up to 2 weeks)
Secondary outcomes:
measure: Safety of online proton adaptive radiotherapy as measured by the amount of grade 2 and higher radiation-related toxicities
timeFrame: from start of treatment through 3 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Allen Mo, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: