Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

About this trial

This study is being done to answer the following question: Is Stereotactic Body Radiation Therapy or SBRT (a form of radiation therapy which can deliver high doses of radiation to the specific painful area of the body most affected by cancer, while keeping the radiation beams away from the healthy parts of the body that surround the cancer) better for pain relief than the standard treatment of conventional radiation therapy or CRT (a form of radiation therapy which delivers radiation to the painful area but can also negatively affect other parts of the body in the same area)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologic confirmation of solid tumour.

Patient with a dominant painful non-spine bone metastasis and a worst minimum pain score of 2 using the BPI attributed to that dominant site

Expected overall survival of greater than 6 months as determined by the treating physician

Suitable for protocol defined SBRT and CRT.

Disqualifiers

Metastases of the hands, feet, cranium or spine (including sacrum) as the dominant/index pain site.

Bone metastasis arising from a small cell or germ cell.

Radionuclide therapy within 30 days of randomization.

Patient treated with prior palliative RT to the dominant painful bone metastasis site (prior radiation exposure is permitted if prior to development of the dominant metastasis and would not influence the applicability of either treatment arm of the current study).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Conventional Radiotherapy

    Radiation

    20Gy in 5 fractions

  • Stereotactic Body Radiotherapy

    Radiation

    30 or 35Gy in 5 fractions

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: Standard Conventional RadiotherapyActive comparator 1 intervention
Group B: Stereotactic Body RadiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete pain response utilizing the Cochran-Mantel-Hanzeal test

Time frame
27 months

Secondary outcomes

1

Pain response pattern at 3 months: partial, stable or progressive pain

Time frame
27 months
2

Early (1 month post RT) and late (6 months post RT) CPR and response patterns (partial, stable, and progressive pain);

Time frame
27 months
3

Re-irradiation rate within the 6-month follow-up period

Time frame
27 months
4

Incidence of fracture at the radiation target site

Time frame
27 months

Other outcomes

Sponsors and contacts

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