Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer

Radiation Therapy Oncology Group

Status and phase: Completed; Phase 3

Conditions: Metastatic Cancer; Breast Cancer; Prostate Cancer; Pain

Treatments: Procedure: pain therapy; Radiation: radiation therapy

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00003162

RTOG-9714

NCI-P97-0124

NCCTG-R9714

CDR0000065957

Details and patient eligibility

About

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective for bone metastases.

PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in treating patients who have bone metastases from breast or prostate cancer.

Full description

OBJECTIVES:

• Compare the ability of a single fraction of radiation therapy vs multiple fractions to provide complete pain relief in patients with painful bone metastases from breast or prostate cancer.
• Determine the frequency and duration of pain relief and narcotic relief after these treatments in these patient populations.
• Compare the effect on quality of life of these two treatments in these patient populations.
• Compare the incidence of pathologic fracture within the treatment fields after these two treatments in these patient populations.

OUTLINE: This is a randomized study.

Patients are assigned to 1 of 2 treatment arms. Arm I consists of radiation therapy delivered in 10 fractions over 2 weeks. Arm II consists of a single dose of radiation therapy. Any retreatment does not occur until at least 4 weeks after prior treatment unless there is an increase of 2 points on the pain score.

Patients are followed and quality of life is assessed at 2 and 4 weeks, then at 2, 3, 6, 9, and 12 months, every 6 months for the next 3 years, then annually until death.

PROJECTED ACCRUAL: This study will accrue 938 patients within 2 years.

Enrollment: 949 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically proven breast or prostate cancer

• Radiographic evidence of bone metastasis within 8 weeks of study

• Eligible treatment sites:

  • Weight-bearing sites:

    • Pelvis (excluding pubis)
    • Femur
    • Sacrum and/or sacroiliac joints
    • Tibia

  • Non-weight-bearing sites:

    • Up to 5 consecutive cervical, thoracic, or lumbar vertebral bodies
    • Lumbosacral spine
    • Up to 3 consecutive ribs
    • Humerus
    • Fibula
    • Radius with/without ulna
    • Clavicle
    • Scapula
    • Pubis

  • If multiple sites are treated, site is included as weight bearing if any of the sites include the pelvis, sacrum, femur, or tibia

• Worst pain score of at least 5 on a scale of 10

• No skull, feet, or hand metastases

• No spinal cord or cauda equina compression/effacement in vertebral metastases

• Multiple sites eligible if they can be included in no greater than 3 treatment sites

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 40-100%

Life expectancy:

• At least 3 months

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No impending fracture of the treatment site
• No hematologic primary malignancies
• Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No change in immunotherapy within 30 days

Chemotherapy:

• No change in chemotherapy within 30 days

Endocrine therapy:

• No change in hormonal therapy within 30 days

Radiotherapy:

• No prior radiation therapy to treatment area
• At least 30 days since systemic radiotherapy (Sr 89)

Surgery:

• No prior palliative surgery to treatment area
• No planned surgical fixation of the bone

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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949 participants in 2 patient groups

3.0 Gy x 10 fractions in two weeks

Active Comparator group

Description:

3.0 Gy x 10 fractions for a total dose of 30.0 Gy in two weeks

Treatment:

Procedure: pain therapy

Radiation: radiation therapy

8.0 Gy x 1 fraction

Experimental group

Description:

8.0 Gy x 1 fraction for a total dose of 8.0 Gy in a single dose

Treatment:

Procedure: pain therapy

Radiation: radiation therapy