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NCT00003162 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2015-11-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    3.0 Gy x 10 fractions for a total dose of 30.0 Gy in two weeks
    intervention Names
    1. Procedure: pain therapy
    2. Radiation: radiation therapy
    label
    3.0 Gy x 10 fractions in two weeks
    type
    ACTIVE_COMPARATOR
  2. description
    8.0 Gy x 1 fraction for a total dose of 8.0 Gy in a single dose
    intervention Names
    1. Procedure: pain therapy
    2. Radiation: radiation therapy
    label
    8.0 Gy x 1 fraction
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. 3.0 Gy x 10 fractions in two weeks
    2. 8.0 Gy x 1 fraction
    name
    pain therapy
    type
    PROCEDURE
  2. arm Group Labels
    1. 3.0 Gy x 10 fractions in two weeks
    2. 8.0 Gy x 1 fraction
    name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
949
type
ACTUAL
Registered outcome plans (not posted results)
Full study description
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.
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.
Source references
references
  1. citation
    Konski A, James J, Hartsell W, Leibenhaut MH, Janjan N, Curran W, Roach M, Watkins-Bruner D. Economic analysis of radiation therapy oncology group 97-14: multiple versus single fraction radiation treatment of patients with bone metastases. Am J Clin Oncol. 2009 Aug;32(4):423-8. doi: 10.1097/COC.0b013e31818da9f7.
    pmid
    19546803
    type
    BACKGROUND
  2. citation
    Bruner DW. Outcomes research in cancer symptom management trials: the Radiation Therapy Oncology Group (RTOG) conceptual model. J Natl Cancer Inst Monogr. 2007;(37):12-5. doi: 10.1093/jncimonographs/lgm004.
    pmid
    17951225
    type
    BACKGROUND
  3. citation
    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.
    type
    BACKGROUND
  4. citation
    Chow E, James J, Barsevick A, Hartsell W, Ratcliffe S, Scarantino C, Ivker R, Roach M, Suh J, Petersen I, Konski A, Demas W, Bruner D. Functional interference clusters in cancer patients with bone metastases: a secondary analysis of RTOG 9714. Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1507-11. doi: 10.1016/j.ijrobp.2009.04.024. Epub 2009 Jul 23.
    pmid
    19632065
    type
    RESULT
  5. citation
    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.
    type
    RESULT
  6. citation
    Hartsell WF, Desilvio M, Bruner DW, Scarantino C, Ivker R, Roach M 3rd, Suh J, Demas WF, Movsas B, Petersen IA, Konski AA. Can physicians accurately predict survival time in patients with metastatic cancer? Analysis of RTOG 97-14. J Palliat Med. 2008 Jun;11(5):723-8. doi: 10.1089/jpm.2007.0259.
    pmid
    18588404
    type
    RESULT
  7. citation
    Konski A, Desilvio M, Hartsell W, Watkins-Bruner D, Coyne J, Scarantino C, Janjan N. Continuing evidence for poorer treatment outcomes for single male patients: retreatment data from RTOG 97-14. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):229-33. doi: 10.1016/j.ijrobp.2006.04.005. Epub 2006 Jul 11.
    pmid
    16814950
    type
    RESULT
  8. citation
    Hartsell WF, Scott CB, Bruner DW, Scarantino CW, Ivker RA, Roach M 3rd, Suh JH, Demas WF, Movsas B, Petersen IA, Konski AA, Cleeland CS, Janjan NA, DeSilvio M. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005 Jun 1;97(11):798-804. doi: 10.1093/jnci/dji139.
    pmid
    15928300
    type
    RESULT
  9. citation
    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.
    type
    RESULT
  10. citation
    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.
    type
    RESULT
  11. citation
    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.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        fraction of 8 Gy has been shown to have similar benefits on bone pain relief and QOL as multiple fractions (3 Gy &#215; 10), as in the <a href="/clinicaltrials/NCT00003162">RTOG-9714</a> trial (NCT00003162).[<a href="#cit/section_8.52">52</a>,<a href="#cit/section_8.53">53</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810021
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        have similar benefits on bone pain relief and QOL as multiple fractions (3 Gy &#215; 10), as in the <a href="/clinicaltrials/NCT00003162">RTOG-9714</a> trial (NCT00003162).[<a href="#cit/section_8.52">52</a>,<a href="#cit/section_8.53">53</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810021&amp;version=HealthProfessional&am
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      Prostate Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice