The CONSOLE Trial - A Randomised trial for the treatment of painful bony metastases not located in the spine using Conventional or Stereotactic Radiotherapy

Phase 3

Recruiting

Conditions: Metastatic Cancer
Cancer - Any cancer

Registration Number: ACTRN12622001200774

Lead Sponsor: Icon Cancer Foundation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 146

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete pain response from SBRT compared to conventional radiotherapy measured by a combination of pain and medication assessment as assessed through completion of a pain and medication diary completed by the patient. Complete response defined to be a pain score of 0 at the treated sites and no associated increase in daily oral morphine equivalent consumption (quantified by oral morphine equivalent daily dose (OMEDD)). [ Assessed 3 months following last day of radiotherapy. ]

Secondary Outcome Measures