Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors

Not Applicable

Active, not recruiting

• Conditions: Sarcoma; Melanoma
• Interventions: Radiation: Pro-GRID

• Registration Number: NCT05121545
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Study Timeline

• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-04
• Study First Posted: 2021-11-16
• Study Start: 2022-04-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pro-GRID treatment Arm	Pro-GRID	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of the Pro-GRID intervention as assessed by success of intervention delivery for a number of participants	1.5 years	To assess the feasibility of successfully creating treatment plans and delivering a novel proton therapy called Pro-GRID. Feasibility will be determined by a successful intervention delivery for 10 of 12 patients with bulky solid tumors.

Secondary Outcome Measures

Name	Time	Method
Change in rate of treatment response of bulky tumors treated and not treated with proton GRID therapy	1, 6 and 12 months post-treatment	To determine the change in response rate for bulky tumors treated and not treated with Proton GRID by Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
Change in degree of treatment response of bulky tumors treated and not treated with proton GRID therapy	1, 6 and 12 months post-treatment	Change in degree of treatment response would be measured by RECIST criteria (partial response, complete response, stable disease, or progression of disease).
Rate of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)	3 months post-treatment	To determine the rate of mild acute toxicity, defined as any CTCAE grade 2 or lower toxicity, and severe acute toxicity, defined as any CTCAE grade 3 or higher toxicity.

Trial Locations

Locations (1)

Sibley Memorial Hospital; 🇺🇸 Washington, District of Columbia, United States