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Trial Title:
Palliative Spatially Fractionated (GRID) Radiotherapy Using Intensity Modulated Proton Therapy
NCT ID:
NCT05831579
Condition:
Unresectable Solid Tumor
Metastatic Cancer
Conditions: Official terms:
Neoplasm Metastasis
Conditions: Keywords:
proton
palliative radiotherapy
spatially fractionated radiotherapy
GRID
stereotactic body radiotherapy (SBRT)
stereotactic ablative radiotherapy (SABR)
cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Proton GRID Radiotherapy
Description:
The proton GRID radiotherapy prescription dose is 20 Gy x 3 fractions to the tumor, with
an integrated dose of 6 Gy x 3 fractions to the PTV. Treatment to multiple lesions within
the PTV is allowed (ex. a dominant lesion plus satellites). Multiple proton GRID
radiotherapy plans may be delivered on the same day or different days, but they cannot
overlap.
Arm group label:
Cohort A: Reirradiation of Treatment Fields
Arm group label:
Cohort B: De Novo Radiation Treatment Fields
Summary:
Spatially fractionated radiotherapy (SFRT or GRID) addresses some limitations of
traditional stereotactic body radiation therapy by relying on beam collimation to create
high-dose "peaks" and intervening low-dose "valleys" throughout the target volume.
Standard palliative radiotherapy regimens provide limited durability of response, and
there are challenges with delivery to large tumors or in previously irradiated fields. In
this study, Proton GRID radiotherapy will be used to deliver three-fraction palliative
radiotherapy to patients with tumors needing palliative radiation. The safety and
efficacy of this approach will be assessed. It is hypothesized that GRID is highly
effective, immunogenic, and associated with low rates of toxicity.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically or cytologically confirmed cancer diagnosis.
- Planning to undergo palliative radiotherapy to unresectable or metastatic target
lesion ≥ 4.5 cm in any dimension as measured with radiographic imaging or with
calipers by clinical exam.
- Cohort A: 10 patients with lesions that have been previously irradiated.
- Cohort B: 10 patients with lesions that have not been previously irradiated.
- ECOG performance status ≤ 3
- 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:
- Patients with tumors in need of urgent surgical intervention, such as
life-threatening bleeding or those at high risk for pathologic fracture and amenable
to surgical intervention.
- Patients with a superficial target lesion ≤ 1 cm deep to skin surface who initially
had a superficial lesion irradiated, if the target lesion was in the area of the
prior irradiation.
- Currently receiving any cytotoxic cancer therapy regimens or VEGF inhibitors that
will overlap with the proton GRID 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. 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.
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:
Anthony Apicelli, M.D.
Phone:
314-362-8610
Email:
apicella@wustl.edu
Investigator:
Last name:
Anthony Apicelli, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Clifford Robinson, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Stephanie Perkins, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Justin Barnes, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Nels Knutson, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Yi Huang, M.S.
Email:
Sub-Investigator
Investigator:
Last name:
Michael Prusator, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Tianyu Zhao, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Xiandong Zhao, Ph.D.
Email:
Sub-Investigator
Start date:
May 12, 2023
Completion date:
May 31, 2026
Lead sponsor:
Agency:
Washington University School of Medicine
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/NCT05831579
http://www.siteman.wustl.edu
