Prospective Evaluation of Interventional Studies on Bone Metastases - the PRESENT Cohort

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUMC Utrecht

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Pain response

Time frame
at 2, 4, 6, 8 weeks, 3 and 6 months, then every 6 months

Secondary outcomes

1

Health-related Quality of Life

Time frame
at 2, 4, 6, 8 weeks and 3 months
2

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.

Time frame
up to 3 months
3

Readmission

Reintervention (reirradiation, surgery, other); Development of neurological symptoms; Development of pathologic fracture

Time frame
up to 3 years
4

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).

Time frame
up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.