ACTIVE_NOT_RECRUITING

Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-06
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05121545

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18
  2. * Histologically or cytologically confirmed invasive cancer
  3. * Bulky tumor \> 7 cm, determined clinically and/or radiographically, at the time of evaluation prior to enrollment
  4. * Treated indicated for palliative intent
  5. * Eastern Cooperative Oncology Group (ECOG) performance status \< 2
  6. * Anticipated treatment deemed safe on pre-review by PI
  7. * For patients with prior Radiation Therapy (RT): Dicoms must be available for dose fusion if overlap anticipated with GRID
  8. * Willing and able to provide informed consent
  9. * Discussion with medical oncology or surgical specialty
  1. * Age \< 18
  2. * ECOG performance status 3-4
  3. * Planned for definitive, curative management
  4. * For patients with prior RT that overlaps with Pro-GRID: Dicoms not available Pregnant women
  5. * Tumor encasing critical structure, as defined by the treating MD.

Contacts and Locations

Principal Investigator

Jean Wright, MD
PRINCIPAL_INVESTIGATOR
Radiation Oncology, SOM

Study Locations (Sites)

Sibley Memorial Hospital
Washington, District of Columbia, 20016
United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  • Jean Wright, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2022-04-06
Study Completion Date2026-12

Study Record Updates

Study Start Date2022-04-06
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Sarcoma
  • Melanoma