Status:
COMPLETED
Single vs Multiple-Fraction Therapy in Treating Patients With Previously Irradiated Painful Bone Metastases
Lead Sponsor:
NCIC Clinical Trials Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Conditions:
Metastatic Cancer
Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * Compare pain relief in patients undergoing single-fraction vs multiple-fraction re-irradiation of painful bone metastases at 2 months after treatment. Secondary * Compare ove...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 22 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2014
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT00080912
Start Date
January 22 2004
End Date
January 16 2014
Last Update
August 21 2023
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
2
The Vitalite Health Network - Dr. Leon Richard
Moncton, New Brunswick, Canada, E1C 8X3
3
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
4
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada, K7L 5P9