NCT00858741

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2009

Completed
Last Updated

March 10, 2009

Status Verified

March 1, 2009

First QC Date

March 6, 2009

Last Update Submit

March 9, 2009

Conditions

Bone MetastasesPain

Keywords

bone metastases from any histological subtype.

Outcome Measures

Primary Outcomes (1)

  • Pain relief

Secondary Outcomes (1)

  • duration of pain relief, narcotic relief, toxicity and the effect on quality of life measures for each of the two treatment arms.

Study Arms (2)

8 Gy arm

EXPERIMENTAL

8.0 Gy in 1 fraction to 8.0 Gy total dose.

Radiation: single fraction

30 Gy arm

ACTIVE COMPARATOR

3.0 Gy x 10 fractions to 30.0 Gy total dose in two weeks.

Radiation: multiple fractions

Interventions

single fractionRADIATION

8 Gy x 1 fraction to 8 Gy total dose in single dose.

8 Gy arm
multiple fractionsRADIATION

3.0 Gy x 10 fractions to 30.0 Gy total dose in two weeks.

30 Gy arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiation Oncology Department at Marilia Medicine school

Marília, São Paulo, 17501570, Brazil

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2009

First Posted

March 10, 2009

Last Updated

March 10, 2009

Record last verified: 2009-03

Locations

BR(1)