Single vs Multiple-Fraction Therapy in Treating Patients With Previously Irradiated Painful Bone Metastases
Metastatic Cancer, Pain
About this trial
This is an interventional treatment trial for Metastatic Cancer focused on measuring bone metastases, pain
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignancy Diagnosis by needle biopsy, bone marrow biopsy, cytology, or surgical biopsy or resection Bone metastases at clinically painful areas confirmed by any of the following: Plain radiographs Radionuclide bone scans CT scans Magnetic resonance imaging Worst pain score of β₯ 2/10 using the baseline Brief Pain Inventory Pain arising from previously irradiated metastases and not from progressive disease in adjoining or remote areas Initial radiotherapy field is reproducible for re-irradiation Current treatment field for palliative radiotherapy must be the same size or smaller than the initial treatment field No clinical or radiological evidence of pathological fractures in the target site extremities. No radiological evidence of high-risk lesions for pathological fractures in the extremities (lytic lesions > 3cm or > 50% cortical erosion of bone diameter) if target site AND patient is a candidate for surgical intervention. No clinical or radiological evidence of spinal cord compression at target site. PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 50-100% Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Not pregnant or nursing Fertile patients must use effective barrier contraception Able and willing to complete quality of life questionnaire in English, French, Dutch, or Spanish (if randomized by Canadian, Dutch, French or RTOG centre) Must be accessible for treatment follow-up Informed consent PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy See Disease Characteristics No more than 1 prior course of radiotherapy to the target site No prior radiotherapy dose β₯ 24 Gy in 6 fractions, 27 Gy in 8 fractions, or 30 Gy in 10 fractions to the spine or any part of the pelvis encompassing small or large bowel and/or the rectum, if these sites are being treated on study Initial doses of 24 Gy in 6 fractions, 27 Gy in 8 fractions or 30 Gy in 10 fractions to the acetabulum or hip and proximal femur allowed as long as the medial field border of the initial treatment did not cross midline No prior radiotherapy dose > 30Gy in 10 fractions to the ribs or extremities if these sites are being treated on study More than 30 days since prior strontium chloride Sr 89 More than 30 days since prior half-body radiotherapy, including the current re-irradiation field At least 4 weeks since initial radiotherapy Surgery No prior palliative surgery in treatment area No concurrent surgical intervention on treatment area Other No prior participation on this protocol No plan to make an immediate change in analgesic regimen
Sites / Locations
- Tom Baker Cancer Centre
- The Vitalite Health Network - Dr. Leon Richard
- Juravinski Cancer Centre at Hamilton Health Sciences
- Cancer Centre of Southeastern Ontario at Kingston
- Grand River Regional Cancer Centre
- Thunder Bay Regional Health Science Centre
- Odette Cancer Centre
- Univ. Health Network-Princess Margaret Hospital
- CHUM - Hopital Notre-Dame
- McGill University - Dept. Oncology
- Centre hospitalier universitaire de Sherbrooke
- Allan Blair Cancer Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I
Arm II
Patients receive single-fraction radiotherapy (8 Gy) on day 1.
Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.