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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003162
Recruitment Status : Completed
First Posted : April 18, 2003
Last Update Posted : November 17, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Metastatic Cancer Pain Prostate Cancer Procedure: pain therapy Radiation: radiation therapy Phase 3

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 949 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life
Study Start Date : February 1998
Actual Primary Completion Date : July 2003

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 3.0 Gy x 10 fractions in two weeks
3.0 Gy x 10 fractions for a total dose of 30.0 Gy in two weeks
 Procedure: pain therapy
Radiation: radiation therapy
Experimental: 8.0 Gy x 1 fraction
8.0 Gy x 1 fraction for a total dose of 8.0 Gy in a single dose
 Procedure: pain therapy
Radiation: radiation therapy


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003162


Locations
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Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Investigators
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Study Chair: William F. Hartsell, MD Advocate Lutheran General Hospital
Study Chair: Ivy A. Petersen, MD Mayo Clinic
More Information
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Publications of Results:
Howell DD, James JL, Hartsell WF, et al.: Randomized trial of short-course versus long-course radiotherapy for palliation of painful vertebral bone metastases: A retrospective analysis of RTOG 97-14. [Abstract] J Clin Oncol 27 (Suppl 15): A-9521, 2009.
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, 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.

Other Publications:
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.

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Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00003162    
Other Study ID Numbers: RTOG-9714
CDR0000065957
NCCTG-R9714
NCI-P97-0124
First Posted: April 18, 2003    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Keywords provided by Radiation Therapy Oncology Group:
stage IV breast cancer
recurrent breast cancer
stage IV prostate cancer
 recurrent prostate cancer
bone metastases
pain
Additional relevant MeSH terms:
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Breast Neoplasms
Prostatic Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases
Neoplastic Processes
Pathologic Processes