Clinical trial NCT02333110: GRID Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors
Official title: Spatially Fractionated Radiation (SFR) Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Symptom relief, as measured using the CTCAE grading system (v4.0) and pain questionnaire
timeFrame: 3 months post treatment
Secondary outcomes:
measure: Acute toxicity of treatment, as measured using the CTCAE grading system (v4.0)
timeFrame: 1 week
measure: Long-term toxicity of treatment, as measured using the CTCAE grading system (v4.0)
timeFrame: 3, 6, 9, 12 months
measure: 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
timeFrame: 3 months
measure: Tumor response, measured on CT-scan
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Sir Mortimer Jewish General Hospital
state: Quebec
Study officials:
affiliation: Sir Mortimer Jewish General Hospital
name: Te Vuong, MD
role: PRINCIPAL_INVESTIGATOR
References: