GRID Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: spatially fractionated radiation therapy.
- Who it may be relevant to
- Registry conditions: Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Spatially Fractionated Radiation (SFR) Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors
Overview
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.
Interventions
- Radiation spatially fractionated radiation therapy
A single dose of 15-20Gys of spatially fractionated radiation therapy
Primary outcome measures
- Symptom relief, as measured using the CTCAE grading system (v4.0) and pain questionnaire [Time frame: 3 months post treatment]
Secondary outcome measures (4)
- Acute toxicity of treatment, as measured using the CTCAE grading system (v4.0) [Time frame: 1 week]
- Long-term toxicity of treatment, as measured using the CTCAE grading system (v4.0) [Time frame: 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]
- Tumor response, measured on CT-scan [Time frame: 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Canada · 1 center
- Sir Mortimer Jewish General Hospital — Montreal
Identifiers
NCT: NCT02333110 · 14-161