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Trial Title:
Online Proton Adaptive Radiotherapy
NCT ID:
NCT06310655
Condition:
Solid Tumor
Conditions: Keywords:
SBRT
proton radiotherapy
reirradiation
Adaptive radiation therapy
Online adaptive radiotherapy
online proton adaptive radiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Proton SBRT
Description:
Patients will receive SBRT over 5 days, either every day or every other day, to a dose of
25-50 Gy.
Arm group label:
Proton Stereotactic Body Radiotherapy (SBRT)
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Allen Mo, M.D., Ph.D.
Phone:
314-717-2320
Email:
amo@wustl.edu
Investigator:
Last name:
Allen Mo, M.D., Ph.D.
Email:
Principal Investigator
Investigator:
Last name:
Hyun Kim, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Stephanie Perkins, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Joshua Schiff, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Weiren Liu, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Hailei Zhang, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Yi Huang, M.S.
Email:
Sub-Investigator
Investigator:
Last name:
Robbie Beckert
Email:
Sub-Investigator
Investigator:
Last name:
Eric Laugeman, M.S.
Email:
Sub-Investigator
Investigator:
Last name:
Farideh Pak, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Mike Watts, M.S.
Email:
Sub-Investigator
Investigator:
Last name:
Xiandong Zhao, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Tianyu Zhao, Ph.D.
Email:
Sub-Investigator
Start date:
May 2, 2024
Completion date:
August 31, 2025
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Collaborator:
Agency:
The Foundation for Barnes-Jewish Hospital
Agency class:
Other
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06310655
http://www.siteman.wustl.edu
