• Pain relief measured by the Brief Pain Inventory at 2 months after treatment [ Designated as safety issue: No ]
  

• Quality of life assessed by the EORTC QLQ-C30 [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Compare pain relief in patients undergoing single-fraction vs multiple-fraction re-irradiation of painful bone metastases.

Secondary

• Compare overall pain relief in patients treated with these regimens.
• Compare time to pain progression in patients treated with these regimens.
• Correlate initial irradiation response with pain relief after re-irradiation in these patients.
• Compare changes in functional interference after re-irradiation using the Brief Pain Inventory in patients treated with these regimens.
• Compare quality of life of patients treated with these regimens (patients in Canada, the Netherlands, and patients registered through RTOG).
• Compare characteristics of non-responders (to both initial and re-irradiation) among patients treated with these regimens.
• Compare the incidence of acute severe radiation-related side effects in patients treated with these regimens.
• Compare the incidence of in-field pathological fractures and spinal cord compression in patients treated with these regimens.

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.

• Arm I: Patients receive single-fraction radiotherapy on day 1.
• Arm II: Patients receive multiple-fraction radiotherapy once daily on days 1-5 or on days 1-8 if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.

At least 4 weeks after the first re-treatment, patients in both arms may receive a second re-treatment in the absence of unacceptable pain progression or unacceptable toxicity.

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. Quality of life is assessed at baseline and then monthly during months 1-6.

Patients are followed for up to 1 year.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 650 patients (325 per treatment arm) will be accrued for this study.

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 site of pain for palliative radiotherapy must be smaller or similar in size to initial treatment field

• No clinical or radiological evidence of pathological fractures in extremities of the area to be re-irradiated, meeting either of the following criteria:

  • Not a candidate for surgical intervention
  • Candidate for surgical intervention AND no high-risk lytic lesion > 3 cm OR > 50% cortical erosion of bone diameter
• No clinical or radiological evidence of spinal cord compression

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
• Must be accessible for treatment follow-up

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

  • 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 intitial treatment did not cross midline
• 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 prior 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