Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation Clinical Trial
Official title:
Spatially Fractionated Radiation (SFR) Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors
| NCT number | NCT02333110 |
| Other study ID # | 14-161 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2015 |
| Est. completion date | December 2025 |
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Sir Mortimer Jewish General Hospital | Montreal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Sir Mortimer B. Davis - Jewish General Hospital |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Symptom relief, as measured using the CTCAE grading system (v4.0) and pain questionnaire | 3 months post treatment | ||
| Secondary | Acute toxicity of treatment, as measured using the CTCAE grading system (v4.0) | 1 week | ||
| Secondary | Long-term toxicity of treatment, as measured using the CTCAE grading system (v4.0) | 3, 6, 9, 12 months | ||
| Secondary | 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 | ||
| Secondary | Tumor response, measured on CT-scan | 8 weeks |