Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05121545

Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sibley Memorial Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Multi-beam proton Pencil Beam Scanning (PBS), termed Pro-GRID

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Change in rate of treatment response of bulky tumors treated and not treated with proton GRID therapy

    Time frame: 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.

  3. Change in degree of treatment response of bulky tumors treated and not treated with proton GRID therapy

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Registry information

Official study title

A Phase 1 Study of Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors (ProGRID)

Acronym: ProGRID

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Nov 16, 2021
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.