TerminatedPhase 3ACTRN12622001200774

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

Conventional or Stereotactic Radiotherapy for the palliation of non-spine bone metastases: A randomised phase III trial.

Sponsor

Icon Cancer Foundation

Enrollment

146 participants

Start Date

Mar 18, 2024

Study Type

Interventional

Conditions

Metastatic Cancer

Summary

The CONSOLE clinical trial aims to compare two schedules of radiotherapy in the treatment of painful cancer that has spread to bones not located in the spine. Who is it for? You may be eligible for this study if you are an adult over the age of 18 who has been diagnosed with cancer that has spread to your bones not located in the spine and is causing you pain. Study details Participants will be randomly assigned to one of two radiotherapy schedules as part of this study. In Arm A, called the conventional treatment or current standard of care, participants will be either given in one (1) treatment on a single day or five (5) treatments over a period of a maximum of seven (7) calendar days for each area which is painful. If you are having more than one area treated, all areas must be completed within 14 calendar days. Each treatment will go for around 15 to 30 minutes. . In Arm B, called Sterotactic Body Radiotherapy (SBRT), participants will be given in two (2) treatments with a minimum of one (1) and a maximum of three (3) days gap between treatments for each area which is painful. If you are having more than one area treated, all areas must be completed within 14 calendar days. radiotherapy which is given in two treatments. Each treatment will take around 30 to 45 minutes. Questionnaires and pain and medication diary will completed at the initial assessment, last day of treatment, 2 weeks after radiotherapy and at 3 and 6 months following the last treatment.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria9

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
-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 Criteria6

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).

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Interventions

ARM B: Stereotactic Body Radiation Therapy (SBRT): 24Gy in 2 fractions delivered with a minimum of 1 and a maximum of 3 days gap days between fractions per treated site. If multiple sites are treated

ARM B: Stereotactic Body Radiation Therapy (SBRT): 24Gy in 2 fractions delivered with a minimum of 1 and a maximum of 3 days gap days between fractions per treated site. If multiple sites are treated, these can be treated on the same day or alternate days and all sites must be treated within 14 calendar days. Patients are required to attend a treatment planning session within 14 days of the start of treatment. The planning procedure will involve a computed-tomography (CT) scan as well as completion of a Magnetic Resonance Imaging (MRI) scan (if one hasn't been done within 6 weeks of starting treatment) and if the study doctor decides it is necessary, also a Positron Emission Tomography (PET) scan. Treatment is expected to take around 45 minutes per treatment. The intervention will be prescribed by a radiation oncologist and administered by radiation therapists. During treatment, imaging will be completed to ensure treatment is administered accurately. All patients will complete quality of life and a pain and medication diary.