A RAndomized trial comparing COnventional with STereotactic radiotherapy for pain reduction and quality of life in spinal metastases "RACOST"

Many patients diagnosed with cancer present with metastatic disease or will
metastasize in time. When there are no curative options, the focus will be
aimed at remaining good quality of life. Spinal metastases will develop
commonly in patients diagnosed with cancer, with an incidence up to 70% of all
bony metastases. Spinal vertebral metastases can give serious pain complaints,
which are likely to progress in time and therewith give a decrease in quality
of life.
Conventional radiotherapy is an effective treatment for pain caused by spinal
metastases. The dose that can be delivered is however limited by the dose to
the spinal cord. One-third of the patients has insufficient pain relief after
treatment and one-fifth of the patients needs retreatment. With the improvement
of systemic therapies, patients live longer and the risk of recurrence
increases. Using stereotactic radiotherapy, a higher local dose can be given
which might give a longer local control and can also be effective in radio
resistant tumors. By using stereotactic radiotherapy, the number of hospital
visits might be reduced and together with the longer pain reduction might lead
to a better quality of life. But stereotactic radiotherapy is technically more
difficult and is therewith more expensive when compared to conventional
treatment. The question to be answered is, whether we can identify a subgroup
of patients that will benefit more from a high dose stereotactic irradiation
and consequently have a better quality of life as compared to the
conventionally used single fraction of low dose radiotherapy.
To investigate this, we will perform a Randomized Phase III trial for
symptomatic spinal metastases.

This study will test the hypothesis that stereotactic radiotherapy gives a
better and longer lasting reduction of pain, local control and therewith a
better quality of life. This in order to optimize and to individualize the
treatment options for the patient.

A randomized multicenter phase III trial comparing stereotactic radiotherapy
(1x20Gy) with conventional radiotherapy (1x8Gy). Complaints due to pain will be
analysed using the validated Dutch Brief Pain Inventory (BPI) which is regarded
to be the most reliable method in use, and side-effects will be recorded using
the Common Toxicity Criteria for Adverse Events (CTCAE). In addition to this
the quality of life will be analysed using the EORTC QOL-C15-PAL and EORTC
QLQ-BM22 questionnaires. For analysis of cost-effectiveness the EQ-5D will be
used.

Both groups undergo an MRI previous to radiotherapy. This is required for the
treatment plan for stereotactic radiotherapy. Patients who are treated with
conventional radiotherapy and who are treated outside of this study would not
normally receive this MRI. Therefore these patients have to have an extra
examination.
The participants will be asked to fill in a quality of life questionaire a
number of times. All of the participants will also be asked to provide a
painscore and information regarding the influence of pain on the quality of
life (BPI en QOL). As well as this there are 5 questions on the health
questionnaire for the cost-effectiveness analysis. This takes place as shown
in the table below, where day 0 the first day of treatment is:

Study flow chart
Before treatment Day 0 Day 1-6 Day 7 Day 8-13
Day14 Month Every 6 months until

1, 1.5,
2-4,6,9,12 5 years
Painscore, medication (BPI) x x x x x x
x x
Questionnaires (QOL) x x x x x x
Health questionnaire (EQ-5D) x x x x x x