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

Sir Mortimer B. Davis - Jewish General Hospital50 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Symptom relief, as measured using the CTCAE grading system (v4.0) and pain questionnaire

Time frame: 3 months post treatment

Secondary Outcomes

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