Palliative Radiotherapy for Bone Metastases: Single Versus Multiple Fractions.

This study has been completed.

First Received: March 6, 2009 Last Updated: March 9, 2009 History of Changes

Sponsored by:	Marilia Medicine School
Information provided by:	Marilia Medicine School
ClinicalTrials.gov Identifier:	NCT00858741

Purpose

The aim of the investigators study was to determine whether 8 Gy in a single fraction provides equivalent pain and narcotic relief compared to 30 Gy in 10 fractions for patients with painful bone metastases. The secondary objectives were to evaluate the frequency, duration of pain relief, narcotic relief, toxicity and the effect on quality of life measures for each of the two treatment arms.

Condition	Intervention	Phase
Bone Metastases Pain	Radiation: single fraction Radiation: multiple fractions	Phase III

MedlinePlus related topics: Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Phase III Study of Palliative Radiotherapy for Bone Metastases Comparing Single to Multiple Fractions.

Further study details as provided by Marilia Medicine School:

Primary Outcome Measures:

Pain relief [ Designated as safety issue: No ]

Secondary Outcome Measures:

duration of pain relief, narcotic relief, toxicity and the effect on quality of life measures for each of the two treatment arms. [ Designated as safety issue: No ]

Enrollment:

148

Arms	Assigned Interventions
8 Gy arm: Experimental 8.0 Gy in 1 fraction to 8.0 Gy total dose.	Radiation: single fraction 8 Gy x 1 fraction to 8 Gy total dose in single dose.
30 Gy arm: Active Comparator 3.0 Gy x 10 fractions to 30.0 Gy total dose in two weeks.	Radiation: multiple fractions 3.0 Gy x 10 fractions to 30.0 Gy total dose in two weeks.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age of 18 years or older, histologically proven primary malignancy of any histological type, radiographic evidence of bone metastasis, pain corresponding to the area of bone metastasis, a Karnofsky performance status of at least 40, and an estimated life expectancy of at least 1 month.
Histologic diagnosis was established from needle biopsy, bone marrow biopsy, cytology, or a surgical biopsy or resection. Radiographic evidence of bone metastasis was required and performed within 8 weeks prior to randomization.

Exclusion Criteria:

The patient was ineligible if the systemic agent commences within the 30 days prior to registration.
This includes hormonal therapy, chemotherapy, and immunotherapy.
Patients were ineligible if the painful area had received prior radiation therapy or palliative surgery, if there was pathologic fracture or impending fracture of the treatment site, or if there was planned surgical fi xation of the bone.
Patients with clinical or radiographic evidence of spinal cord or cauda equina compression and/or effacement were not eligible.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858741

Locations

Brazil, Sao Paulo
Radiation Oncology Department at Marilia Medicine school
Marilia, Sao Paulo, Brazil, 17501570

Sponsors and Collaborators

Marilia Medicine School

More Information

No publications provided

Responsible Party:	Marilia Medicine School ( Gustavo Viani Arruda )
Study ID Numbers:	FAMEMA - BONE METASTASES
Study First Received:	March 6, 2009
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00858741 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Marilia Medicine School:

bone metastases from any histological subtype.

Study placed in the following topic categories:

Musculoskeletal Diseases
Bone Neoplasms
Hematologic Diseases
Neoplasm Metastasis

Pain
Bone Marrow Diseases
Bone Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Musculoskeletal Diseases

Bone Neoplasms
Hematologic Diseases
Neoplasm Metastasis
Bone Marrow Diseases
Bone Diseases

ClinicalTrials.gov processed this record on May 06, 2009