Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors

NCT05121545 | Active Not Recruiting DMC

• 2 other identifiers: J2161IRB00289810
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma; Melanoma

Keywords

Spatially-fractionated radiotherapy; GRID-therapy; Proton therapy; Sarcoma; Melanoma; Treatment resistant tumors

Outcome Measures

Primary Outcomes (1)

• Feasibility of the Pro-GRID intervention as assessed by success of intervention delivery for a number of participants

  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.

  1.5 years

Secondary Outcomes (3)

• Rate of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)

  3 months post-treatment

• Change in rate 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 of bulky tumors treated and not treated with proton GRID therapy

  1, 6 and 12 months post-treatment

Study Arms (1)

Pro-GRID treatment Arm

OTHER

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.

Radiation: Pro-GRID

Interventions

Pro-GRID RADIATION

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.

Also known as: Multi-beam proton Pencil Beam Scanning (PBS), termed Pro-GRID

Pro-GRID treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

MeSH Terms

Conditions

Sarcoma; Melanoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jean Wright, MD

  Radiation Oncology, SOM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 16, 2021
• Study Start: April 6, 2022
• Primary Completion: September 24, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)