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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

July 29, 2009

Start Date ^ICMJE

February 1998

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00003162 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Active Control

Condition ^ICMJE

Breast Cancer
Metastatic Cancer
Pain
Prostate Cancer

Intervention ^ICMJE

Procedure: pain therapy
Radiation: radiation therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

938

Completion Date

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00003162

Responsible Party

Study ID Numbers ^ICMJE

CDR0000065957, RTOG-9714, NCCTG-R9714, NCI-P97-0124

Study Sponsor ^ICMJE

Radiation Therapy Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)
North Central Cancer Treatment Group

Investigators ^ICMJE

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

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP