Clinical trial NCT05121545: Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors
Official title: A Phase 1 Study of Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors (ProGRID)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sarcoma
Melanoma
Keywords: Spatially-fractionated radiotherapy
GRID-therapy
Proton therapy
Sarcoma
Melanoma
Treatment resistant tumors
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm phase I study design, evaluating the feasibility (primary endpoint), toxicity (secondary endpoint), and degree of response (exploratory endpoint) after proton GRID therapy in patients with bulky tumors.
Primary purpose: TREATMENT

Brief summary: This is a single arm, phase I study, evaluating the feasibility, toxicity, and degree of tumor response after novel proton pencil beam scanning (PBS GRID) treatment in patients with bulky tumors that are difficult to manage.

Detailed description: The proton group at Sibley Memorial Hospital has developed a new method for multi-beam proton delivery making it possible to arrange and optimize GRID dosimetry and normal tissue sparing compared to other similar techniques.

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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* 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:

* Age \< 18
* 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.

Primary outcomes:
measure: Feasibility of the Pro-GRID intervention as assessed by success of intervention delivery for a number of participants
timeFrame: 1.5 years
Secondary outcomes:
measure: Rate of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)
timeFrame: 3 months post-treatment
measure: Change in rate of treatment response of bulky tumors treated and not treated with proton GRID therapy
timeFrame: 1, 6 and 12 months post-treatment
measure: Change in degree of treatment response of bulky tumors treated and not treated with proton GRID therapy
timeFrame: 1, 6 and 12 months post-treatment
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
Study officials:
affiliation: Radiation Oncology, SOM
name: Jean Wright, MD
role: PRINCIPAL_INVESTIGATOR
References: