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RecruitingLast updated: 8 February 2024

CONSOLE: This trial is comparing two schedules of radiation therapy in the treatment of painful cancer that has spread to bones but is not located in the spineConventional or Stereotactic Radiotherapy for the palliation of non-spine bone metastases: A randomised phase III trial.

Clinical summary

Summary

Eligible participants will be randomly assigned to one of two radiation therapy schedules.

In Arm A (current standard of care), participants will receive conventional radiation therapy which will be either given in one treatment on a single day, or five treatments over a period of a maximum of seven 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, participants will receive Sterotactic Body Radiotherapy (SBRT) in two treatments with a minimum of one and a maximum of three 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. Each treatment will take around 30 to 45 minutes.

Questionnaires and pain and medication diary will be completed at the initial assessment, last day of treatment, 2 weeks after radiation therapy, and at 3 and 6 months following the last treatment.

Conditions

This trial is treating patients with metastatic cancer that has spread to the bones but is not located in the spine

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

III

Trial Acronym

CONSOLE

More information

Trial Identifiers

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Trial sponsor

Icon Cancer Foundation

Scientific Title

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

Eligibility

Inclusion

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

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).

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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