About this trial
Bone metastases are frequent distant manifestations of cancer, with pain as a common and devastating consequence. The primary treatment for painful bone metastases, external beam radiation therapy, is moderately effective: about 60% of patients who undergo conventional radiotherapy experience (partial) pain relief. Several factors associated with treatment failure have been identified, but no attempts have been made to collapse these factors into a clinically useful prediction tool to predict treatment response. In addition, to aid in therapy selection based on expected survival time, development of survival models is essential. Finally, we need innovative treatments as alternatives or additive to standard treatment options to improve quality of life (QoL). For these reasons, we set up the PRESENT cohort study, recruiting patients at the departments of radiation oncology and orthopedic surgery.
We aim to provide detailed information about clinical data, create an infrastructure for efficient, fast and pragmatic evaluation and implementation of innovative interventions, as well as development of accurate new prediction tools.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologic proof of malignancy;
Radiographic or histologic proof of metastatic bone disease;
Undergoing radiotherapy;
Age > 18 years;
Disqualifiers
Mentally incompetent patients;
Life expectancy < 1 week indicated by the treating physician.
Trial population
All patients with bone metastases undergoing radiotherapy will be asked to participate in this cohort study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Pain response
Secondary outcomes
Health-related Quality of Life
Toxicity according to CTCAE version 4
Grade 3 and 4 side effects occurring during or up to 3 months after radiotherapy will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE version 4). The following side effects will be registered: Nausea; Vomiting; Diarrhoea; Pain flare.
Readmission
Reintervention (reirradiation, surgery, other); Development of neurological symptoms; Development of pathologic fracture
Survival
Survival of participating patients will be recorded using the follow up questionnaires (returned by family members) or are derived from the Municipal Personal Records Database (in Dutch: Gemeentelijke Basisadministratie, GBA).
Sponsors and contacts
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