Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors (ProGRID)

May 30, 2023 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Radiation: 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 Names:
  • Multi-beam proton Pencil Beam Scanning (PBS), termed Pro-GRID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months post-treatment
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.
1, 6 and 12 months post-treatment
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).
1, 6 and 12 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

  • Principal Investigator: Jean Wright, MD, Radiation Oncology, SOM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 4, 2021

First Submitted That Met QC Criteria

November 4, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J2161
  • IRB00289810 (Other Identifier: JHM IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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