GRID Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors

Spatially Fractionated Radiation (SFR) Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors

Palliative radiation therapy represents 40% of the on-going radiation at the Jewish General Hospital. In a traditional palliative radiation treatment to bulky or radioresistant tumors, radiotherapy schema varies from 24 to 30 Gys given in 3 to 10 fractions, depending on the tumor size, tumor location and tumor pathology. However, for many patients this treatment involves considerable toxicity, travel and time spent at the hospital. Spatially fractionated radiation (SFR) is an alternative technique that consists in delivering one single treatment, given through a grid containing holes. The present study is proposing to validate SFR as a safe and effective mean to palliate patients with symptomatic bulky tumors (more than 8 cm) or with tumors known to be resistant to radiation.

Study Overview

• Status: Recruiting
• Conditions: Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation
• Intervention / Treatment: Radiation: spatially fractionated radiation therapy

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luciana Poggi, PhD; Phone Number: 28443 514-340-8222; Email: luciana.poggi.trinidad.ccomtl@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Recruiting
      • Sir Mortimer Jewish General Hospital
      • Contact: Harielle Lamarre, BSc; Phone Number: 26199 514-340-8222; Email: hlamarre@jgh.mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient with histologically or cytologically confirmed malignancy. All malignant histologies/cytologies are eligible.
• Patient with bulky tumor (larger than 8cm), or with a tumor known to be resistant to radiation (eg. Melanoma, hypernephroma, sarcoma), or with a tumor previously irradiated with a palliative intent requiring more than 1 fraction of radiation
• Patient planned to undergo palliative radiation therapy treatments to one of the following 5 sites: extremities, neck, chest, abdomen and pelvis
• WHO performance status of 0-2
• Aged 18 years or older
• Ability to sign and understand an informed consent form

Exclusion Criteria:

• Potentially curable patient
• Previous palliative radiation with hypofractionation
• Tumor located near the spinal cord or in the brain
• Pregnant or nursing woman

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GRID radiation therapy; A single dose of 15-20Gys of spatially fractionated radiation therapy	Radiation: spatially fractionated radiation therapy; A single dose of 15-20Gys of spatially fractionated radiation therapy; Other Names: GRID radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Symptom relief, as measured using the CTCAE grading system (v4.0) and pain questionnaire	3 months post treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Acute toxicity of treatment, as measured using the CTCAE grading system (v4.0)	1 week
Long-term toxicity of treatment, as measured using the CTCAE grading system (v4.0)	3, 6, 9, 12 months
Cost-effectiveness, as measured by evaluating the cost of the procedure per patient and the efficacy of treatment with regards to symptom relief and tumor response	3 months
Tumor response, measured on CT-scan	8 weeks

Collaborators and Investigators

• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Investigators: Principal Investigator: Te Vuong, MD, Sir Mortimer Jewish General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 22, 2014
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimated): January 7, 2015

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 14-161