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Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases: a Randomized Phase II/III Trial


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Bone Metastases

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Trial Information

Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases: a Randomized Phase II/III Trial


Inclusion Criteria:



- Painful bone metastasis of solid tumors

- Pain score minimum of 2 on a scale of 10

- A maximum number of painful bone metastases: 3 or more

- Life expectancy > 3 months

- Age minimum 18 years old

- Signed informed consent

Exclusion Criteria:

- Tumor histology (renal cell and melanoma vs. other solid tumors)

- VAS pain score (<5 vs. 6-10).

- Bisphosphonate use (yes vs. no)

- Opioid analgesics (yes vs. no)

- Corticosteroid use (yes vs. no)

- Spine vs non-spine localisation

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Level of pain response 1 month after radiotherapy

Outcome Description:

Pain is measured with the visual analogue scale. Response is scored in accordance to the guidelines of the international consensus on palliative radiotherapy.

Outcome Time Frame:

1 month after radiotherapy

Safety Issue:

No

Principal Investigator

Wilfried De Neve, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent

Authority:

Belgium: Ethics Committee

Study ID:

2011/541

NCT ID:

NCT01429493

Start Date:

February 2013

Completion Date:

January 2014

Related Keywords:

  • Bone Metastases
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases

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