CONSOLE
Conventional or Stereotactic Radiotherapy for the palliation of non-spine bone metastases: A randomised phase III trial.
Trial summary:
The CONSOLE Trial – A Randomised trial for the treatment of painful bony metastases not located in the spine using Conventional or Stereotactic Radiotherapy
Receptor status / problem studied:
Painful bony metastases not located in the spine
Inclusion criteria
Age 18 years or older
World Health Organisation Performance Status (WHO PS) 0-2
Histological confirmation of primary malignancy (exclude seminoma, Small Cell lung Cancer (SCLC) and haematological malignancies)
Able to consent to trial
Able to safely deliver SBRT and conventional radiotherapy to all sites of disease
Life expectancy >6 months
Able to complete QoL and pain questionnaires
1-3 Lesions <5cm in maximum dimension suitable for SBRT (excluding skull and mandible) with baseline pain score of at least 2 in target area. Lesions can be in close proximity and included in the one plan/treatment area if required.
Patients with spinal or intracranial metastases are eligible for inclusion but these sites will not be treated or assessed for the purpose of this trial
Exclusion criteria
Patients who are candidates for curative intent or disease-modifying treatment for oligometastatic disease
Patients unable or unwilling to comply with protocol requirements.
Pregnancy or trying to become pregnant
High fracture risk requiring fixation, Mirel’s score greater than or equal to 9
Chemotherapy or Immunotherapy within one week of radiotherapy
Previous radiotherapy at the treatment site(s).
Trial Title
CONSOLE
Diagnosis
Advanced solid tumours
Type of trial
Investigator Initiated
Type of treatement
Radiation Oncology
Phase
III