A Phase III International Randomized Trial Of Single Versus Multiple Fractions For Re-Irradiation Of Painful Bone Metastases
A Phase III International Randomized Trial Of Single Versus Multiple Fractions For Re-Irradiation Of Painful Bone Metastases
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to response to initial radiotherapy (yes vs no), initial fractionation (single fraction vs multiple fraction), and participating center. Patients are randomized to 1 of 2 treatment arms.
At least 4 weeks after the first re-treatment, patients in both arms may receive a second re-treatment at the discretion of the treating oncologist.
Patients complete a Brief Pain Inventory questionnaire at baseline, on days 7 and 14, monthly during months 1-6, and at months 9 and 12. Acute Toxicities are assessed on days 7 and 14. Quality of Life is assessed at baseline and then monthly during months 1-6 for patients from participating groups.
Patients are followed for up to 1 year.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 850 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignancy
Bone metastases at clinically painful areas confirmed by any of the following:
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
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
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
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
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
Other