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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Radiation Therapy Oncology Group
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003162
  Purpose

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 Intervention Phase
Breast Cancer
Metastatic Cancer
Pain
Prostate Cancer
Procedure: pain therapy
Procedure: radiation therapy
Phase III

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Prostate Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Active Control
Official Title:   Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   938
Study Start Date:   February 1998

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
    • 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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003162

Show 253 study locations  Show 253 Study Locations

Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
North Central Cancer Treatment Group

Investigators
Study Chair:     William F. Hartsell, MD     Lutheran General Hospital    
Study Chair:     Ivy A. Petersen, MD     Mayo Clinic    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Hartsell WF, Desilvio M, Bruner DW, Scarantino C, Ivker R, Roach M, 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.
 
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. Epub 2006 Jul 11.
 
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.
 
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.
 

Other Publications:
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.
 
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.
 

Study ID Numbers:   CDR0000065957, RTOG-9714, NCCTG-R9714, NCI-P97-0124
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003162
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer  
recurrent breast cancer  
stage IV prostate cancer  
recurrent prostate cancer
bone metastases
pain

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Skin Diseases
Neoplasm Metastasis
Quality of Life
Breast Neoplasms
Urogenital Neoplasms
Pain
Genital Diseases, Male
Prostatic Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on September 19, 2008




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