Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors
NCT ID: NCT05121545
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
11 participants
INTERVENTIONAL
2022-04-06
2026-12-31
Brief Summary
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Detailed Description
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In this phase I pilot study, patients with bulky tumors will receive this novel method of GRID-therapy also called spatially-fractionated radiotherapy which involves delivering high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor and is often aligned in a grid pattern.
In so doing, this study will ascertain the feasibility, safety and tumor response i.e. shrinkage and resectability of this treatment. Ultimately, the goal is to improve local outcomes of patients with bulky tumors and to offer new treatment options for patients with difficult-to-manage bulky tumors.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pro-GRID treatment Arm
Patients enrolled in this study will receive spatially-fractionated radiotherapy or GRID-therapy, which involves delivering a one-time treatment of high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor. Patients will receive 2 (lowest dose) to 18 Gy (highest dose) in a single fraction.
Pro-GRID
Study participants will receive a single treatment of Pro-GRID therapy. After which, the participants would be able to resume standard therapy (after one week) and receive additional radiotherapy one month after Pro-GRID therapy, if recommended. Participants will be in the study for one year. Follow-up appointments will be scheduled at 1, 3, 6 and 12 months posttreatment, and may include a history and physical exam, labs and/or a CT scan and toxicity assessments.
Interventions
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Pro-GRID
Study participants will receive a single treatment of Pro-GRID therapy. After which, the participants would be able to resume standard therapy (after one week) and receive additional radiotherapy one month after Pro-GRID therapy, if recommended. Participants will be in the study for one year. Follow-up appointments will be scheduled at 1, 3, 6 and 12 months posttreatment, and may include a history and physical exam, labs and/or a CT scan and toxicity assessments.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed invasive cancer
* Bulky tumor \> 7 cm, determined clinically and/or radiographically, at the time of evaluation prior to enrollment
* Treated indicated for palliative intent
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2
* Anticipated treatment deemed safe on pre-review by PI
* For patients with prior Radiation Therapy (RT): Dicoms must be available for dose fusion if overlap anticipated with GRID
* Willing and able to provide informed consent
* Discussion with medical oncology or surgical specialty
Exclusion Criteria
* ECOG performance status 3-4
* Planned for definitive, curative management
* For patients with prior RT that overlaps with Pro-GRID: Dicoms not available Pregnant women
* Tumor encasing critical structure, as defined by the treating MD.
18 Years
ALL
No
Sponsors
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Jean Wright, MD
Role: PRINCIPAL_INVESTIGATOR
Radiation Oncology, SOM
Locations
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Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Countries
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Other Identifiers
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IRB00289810
Identifier Type: OTHER
Identifier Source: secondary_id
J2161
Identifier Type: -
Identifier Source: org_study_id