Palliative Lattice Stereotactic Body Radiotherapy (SBRT)
October 22, 2021 updated by: Washington University School of Medicine
A Trial of Palliative Lattice Stereotactic Body Radiotherapy (SBRT)
Standard palliative radiotherapy regimens may provide limited durability of response in large tumors.
Thus, there is a clinical need for a new approach.
The Lattice SBRT approach will deliver 20 Gy in 5 fractions with partial volume simultaneous integrated boosts to 66.7 Gy.
This is hypothesized to improve symptom response, local control, and better prime the tumor microenvironment for immune response compared with standard palliative radiotherapy doses.
It is also hypothesized that this will be associated with less toxicity than the traditional homogenous SBRT plan delivered to a large tumor.
Blood will be collected before and after Lattice SBRT for evaluation of the peripheral blood immune microenvironment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically or cytologically confirmed cancer.
- Planning to undergo palliative radiotherapy to a lesion ≥ 4.5 cm as measured with radiographic imaging or with calipers by clinical exam.
- ECOG performance status ≤ 2
- At least 18 years of age.
- Radiotherapy is known to be teratogenic. For this reason, 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, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 6 months after completion of the study
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
- Prior radiotherapy that overlaps with any planned site of protocol radiotherapy.
- Patients with tumors in need of urgent surgical intervention, such as life-threatening bleeding or those at high risk for pathologic fracture.
Currently receiving any cytotoxic cancer therapy regimens or VEGF inhibitors that will overlap with the Lattice SBRT administration.
*Cytotoxic chemotherapy and VEGF inhibitors prior to radiotherapy or planned after radiotherapy delivery are allowed at the discretion of the treating radiation oncologist. This includes continuing a treatment plan which was initiated prior to the start of radiotherapy. A 2 week washout is recommended, but not required.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 20 days of study entry.
- Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended. Recommend exclusion of specific ART agents based on predicted drug-drug interactions (i.e. for sensitive CYP3A4 substrates, concurrent strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) should be contraindicated).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Lattice stereotactic body radiation therapy
-Lattice SBRT prescribed to a dose of 20 Gy in 5 fractions with a simultaneous integrated boosts of 66.7 Gy in 5 fractions
|
-As long as radiotherapy fields do not overlap, treatment of up to 4 other tumor sites are allowed
Other Names:
-Before treatment, immediately after radiotherapy completion, 14 days after radiotherapy, and 30 days after radiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Patients With Treatment-related, Non-hematologic, Grade 3 or Higher Adverse Events
Time Frame: Through 90 days following completion of radiotherapy (estimated to be 90 days and 2 weeks)
|
-Measured by CTCAE version 5.0
|
Through 90 days following completion of radiotherapy (estimated to be 90 days and 2 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 31, 2019
Primary Completion (ACTUAL)
December 14, 2020
Study Completion (ACTUAL)
December 14, 2020
Study Registration Dates
First Submitted
October 17, 2019
First Submitted That Met QC Criteria
October 17, 2019
First Posted (ACTUAL)
October 21, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 22, 2021
Last Update Submitted That Met QC Criteria
October 22, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 201910071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.