N/A
N=850
Single vs Multiple-Fraction Therapy in Treating Patients With Previously Irradiated Painful Bone Metastases
Metastatic Cancer · Pain
Bottom Line
View on ClinicalTrials.gov: NCT00080912 ↗Enrolled (actual)
850
Serious AEs
0.1%
Results posted
Feb 2015
Primary outcome: Primary: Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment — 28.0; 32.0 percentage of participants — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NCIC Clinical Trials Group
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment |
28.0; 32.0 | 0.03 sig |
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether single-fraction (single-dose) re-irradiation therapy is as effective as multiple-fraction (many small doses of radiation therapy) re-irradiation therapy in relieving bone pain caused by bone metastases.
PURPOSE: This randomized phase III trial is studying single-dose radiation therapy to see if it works as well as multiple-dose radiation therapy in treating patients previously irradiated with painful bone metastases.
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 ≥ 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 ≥ 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
Data sourced from ClinicalTrials.gov (NCT00080912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.