RECRUITING
I'm interested ...!!
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.
Conditions:
🦠 Sarcoma 🦠 Melanoma
🗓️ Study Start (Actual) 6 April 2022
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2026
👥 Enrollment (Estimated) 12
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Washington, District of Columbia, United States

📋 Eligibility Criteria

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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 4 November 2021
  • First Submitted that Met QC Criteria 4 November 2021
  • First Posted 16 November 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 June 2024
  • Last Update Posted 7 June 2024
  • Last Verified June 2024
I'm interested ...!!