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Palliative Radiotherapy for Bone Metastases: Single Versus Multiple Fractions.

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ClinicalTrials.gov Identifier: NCT00858741
Recruitment Status : Completed
First Posted : March 10, 2009
Last Update Posted : March 10, 2009
Sponsor:
Information provided by:
Marilia Medicine School

Brief Summary:

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 or disease Intervention/treatment Phase
Bone Metastases Pain Radiation: single fraction Radiation: multiple fractions Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study of Palliative Radiotherapy for Bone Metastases Comparing Single to Multiple Fractions.

Arm Intervention/treatment
Experimental: 8 Gy arm
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.

Active Comparator: 30 Gy arm
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.




Primary Outcome Measures :
  1. Pain relief

Secondary Outcome Measures :
  1. duration of pain relief, narcotic relief, toxicity and the effect on quality of life measures for each of the two treatment arms.


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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

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.

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): NCT00858741


Locations
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Brazil
Radiation Oncology Department at Marilia Medicine school
Marilia, Sao Paulo, Brazil, 17501570
Sponsors and Collaborators
Marilia Medicine School

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Responsible Party: Gustavo Viani Arruda, Marilia Medicine School
ClinicalTrials.gov Identifier: NCT00858741     History of Changes
Other Study ID Numbers: FAMEMA - BONE METASTASES
First Posted: March 10, 2009    Key Record Dates
Last Update Posted: March 10, 2009
Last Verified: March 2009
Keywords provided by Marilia Medicine School:
bone metastases from any histological subtype.
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases