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

Not Applicable

Recruiting

• Conditions: Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation
• Interventions: Radiation: spatially fractionated radiation therapy

• Registration Number: NCT02333110
• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-22
• Study Start: 2015-01
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-07
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-25
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GRID radiation therapy	spatially fractionated radiation therapy	A single dose of 15-20Gys of spatially fractionated radiation therapy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Tumor response, measured on CT-scan	8 weeks
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
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

Trial Locations

Locations (1)

Sir Mortimer Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada