NCT00003162

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

Official Title:

Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life

Summary

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.

Eligibility

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

Disease(s) and\or Condition(s)

Breast Cancer

Metastatic Cancer

Pain

Prostate Cancer

Primary Purpose
  • SUPPORTIVE_CARE
Intervention/Treatment
    • Type: PROCEDURE
    • Name: pain therapy
    • Description:
    • Arm Group Labels: 3.0 Gy x 10 fractions in two weeks, 8.0 Gy x 1 fraction
    • Type: RADIATION
    • Name: radiation therapy
    • Description:
    • Arm Group Labels: 3.0 Gy x 10 fractions in two weeks, 8.0 Gy x 1 fraction
Sponsor
  • Radiation Therapy Oncology Group