Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Closed 18 and over NCI RTOG-9714 NCCTG-R9714, NCI-P97-0124, NCT00003162

Objectives

1. 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.
2. Determine the frequency and duration of pain relief and narcotic relief after these treatments in these patient populations.
3. Compare the effect on quality of life of these two treatments in these patient populations.
4. Compare the incidence of pathologic fracture within the treatment fields after these two treatments in these patient populations.

Entry 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
  • Nonweight 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

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

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

Expected Enrollment

This study will accrue 938 patients within 2 years.

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.

Hartsell WF, Desilvio M, Bruner DW, et al.: Can physicians accurately predict survival time in patients with metastatic cancer? Analysis of RTOG 97-14. J Palliat Med 11 (5): 723-8, 2008.[PUBMED Abstract]

Konski A, Desilvio M, Hartsell W, et al.: Continuing evidence for poorer treatment outcomes for single male patients: retreatment data from RTOG 97-14. Int J Radiat Oncol Biol Phys 66 (1): 229-33, 2006.[PUBMED Abstract]

Hartsell WF, Scott CB, Bruner DW, et al.: Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst 97 (11): 798-804, 2005.[PUBMED Abstract]

Hartsell WF, Winter K, Bruner DW, et al.: Breast cancer patients have better outcomes than prostate cancer patients for palliation of painful bone metastases: results of RTOG 97-14. [Abstract] J Clin Oncol 23 (Suppl 16): A-6073, 546s, 2005.

Bruner DW, Winter K, Hartsell W, et al.: Prospective health-related quality of life valuations (utilities) of 8 Gy in 1 fraction vs 30 Gy in 10 fractions for palliation of painful bone metastases: preliminary results of RTOG 97–14. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-23, S142, 2004.

Hartsell WF, DeSilvio M, Bruner DW, et al.: Can physicians accurately predict survival time in patients with metastatic cancer? Analysis of RTOG 9714. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-25, S143, 2004.

Hartsell WF, Scott C, Bruner DW, et al.: Phase III randomized trial of 8 Gy in 1 fraction vs. 30 Gy in 10 fractions for palliation of painful bone metastases: preliminary results of RTOG 97-14. [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S124, 2003.

Bruner DW: Outcomes research in cancer symptom management trials: the Radiation Therapy Oncology Group (RTOG) conceptual model. J Natl Cancer Inst Monogr (37): 12-5, 2007.[PUBMED Abstract]

Juliano JJ, Reddy CA, Videtic GMM: How fast does practice change? A single-institution experience in utilization of a single fraction for palliation of bone metastases before and after RTOG 9714. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2561, S521-2, 2006.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

William Hartsell, MD, Protocol chair		Ph: 847-723-8030 Email: william.hartsell-md@advocatehealth.com

North Central Cancer Treatment Group

Ivy Petersen, MD, Protocol chair		Ph: 507-284-2669

Registry Information
Official Title		Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life
Trial Start Date		1998-02-01
Registered in ClinicalTrials.gov		NCT00003162
Date Submitted to PDQ		1997-12-15
Information Last Verified		2002-04-05
NCI Grant/Contract Number		CA21661