Solid Tumor
Conditions
Keywords
SBRT, proton radiotherapy, reirradiation, Adaptive radiation therapy, Online adaptive radiotherapy, online proton adaptive radiotherapy
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.
Interventions
RADIATIONProton SBRT
Patients will receive SBRT over 5 days, either every day or every other day, to a dose of 25-50 Gy.
Sponsors
Washington University School of Medicine
The Foundation for Barnes-Jewish Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Online Proton Adaptive Radiotherapy | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety of Online Proton Adaptive Radiotherapy as Measured by the Number of Grade 2 and Higher Radiation-related Toxicities | From start of treatment through 3 months | Adverse events (AEs) are graded per CTCAE v5.0. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael Waters, M.D.
Washington University School of Medicine
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 61.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 2 / 10 |
Outcome results
None listed