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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Luciana Poggi, PhD
- Phone Number: 28443 514-340-8222
- Email: luciana.poggi.trinidad.ccomtl@ssss.gouv.qc.ca
Study Locations
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: GRID radiation therapy
A single dose of 15-20Gys of spatially fractionated radiation therapy
|
A single dose of 15-20Gys of spatially fractionated radiation therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Symptom relief, as measured using the CTCAE grading system (v4.0) and pain questionnaire
Time Frame: 3 months post treatment
|
3 months post treatment
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Acute toxicity of treatment, as measured using the CTCAE grading system (v4.0)
Time Frame: 1 week
|
1 week
|
|
Long-term toxicity of treatment, as measured using the CTCAE grading system (v4.0)
Time Frame: 3, 6, 9, 12 months
|
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
Time Frame: 3 months
|
3 months
|
|
Tumor response, measured on CT-scan
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Te Vuong, MD, Sir Mortimer Jewish General Hospital
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 14-161
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