Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Bone Metastases

Treatments: Procedure: Biological imaging guided antalgic radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00503178

2006/098

Details and patient eligibility

About

Highly selective irradiation requires accurate target definition by high-resolution three-dimensional imaging. Co-registration of FDG-PET and high-resolution CT might be the imaging modality of choice. This choice might target radiation therapy precisely to the intra-osseous volume that is responsible for pain and to spare selectively healthy bone in the vicinity of the metastasis. This strategy could result in equal anti-pain efficacy as conventional large volume radiotherapy, but could allow bone remodeling and preservation of bone structural strength in the vicinity and could lead to reduced toxicity to neighboring organs.

Enrollment: 54 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Painful bone metastasis of solid tumors
• A maximum number of bone metastases less or equal to 3
• Life expectancy > 6 months
• Minimum age 21 years
• Signed informed consent

Exclusion criteria

• Previous radiotherapy to the painful site
• Bone metastasis from malignant melanoma or renal cell carcinoma
• Associated fracture or extra-osseous component

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Patients undergoing imaging guided radiotherapy.

Experimental group

Treatment:

Procedure: Biological imaging guided antalgic radiotherapy