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

Study Overview
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Brief Summary
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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.

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

Conditions
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Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation

Intervention / Treatment
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* Radiation: spatially fractionated radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GRID radiation therapy<br>A single dose of 15-20Gys of spatially fractionated radiation therapy | Radiation: spatially fractionated radiation therapy<br>* A single dose of 15-20Gys of spatially fractionated radiation therapy<br>* Other names: GRID radiation therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |