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

Recruiting

• Conditions: Bone Metastases

• Registration Number: NCT02356497
• Lead Sponsor: UMC Utrecht

Brief Summary

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.

Detailed Description

The PRESENT cohort is set up according to the 'cohort multiple Randomised Controlled Trial' design. The basis of this design is a prospective cohort of patients with bone metastases, receiving care as usual, who give informed consent for cohort participation. At the UMC Utrecht, patients are furthermore asked for informed consent to be randomized in future RCTs conducted within the cohort. Patients are informed that they will be offered the experimental intervention if they are randomly selected. They are also informed that they otherwise might serve as controls without being notified and that their data can be used in a trial context. For each patient in the cohort, clinical and patient-reported outcomes are captured at baseline and at regular intervals during follow-up. Within this cohort, multiple RCTs can be conducted. For this purpose, eligible patients who have provided the consent required for them to participate in an RCT within the cohort are identified. From this subcohort, a random selection of patients will be invited to undergo the experimental intervention. Eligible participants who were not randomly selected receive standard care, are not informed about the experimental intervention and serve as controls. Outcomes in this control group are compared with the outcomes of those who were offered the experimental intervention, in order to estimate the effect of the experimental intervention versus usual care. Within the cohort, the same process can be repeated for trials of other interventions.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2015-02-01
• Study First Submitted QC: 2015-02-01
• Study First Posted: 2015-02-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• Histologic proof of malignancy;
• Radiographic or histologic proof of metastatic bone disease;
• Undergoing radiotherapy;
• Age > 18 years;
• Informed consent - at least - for use of routinely collected clinical data.

Exclusion Criteria

• Mentally incompetent patients;
• Life expectancy < 1 week indicated by the treating physician.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain response	at 2, 4, 6, 8 weeks, 3 and 6 months, then every 6 months

Secondary Outcome Measures

Name	Time	Method
Toxicity according to CTCAE version 4	up to 3 months	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.
Health-related Quality of Life	at 2, 4, 6, 8 weeks and 3 months
Survival	up to 3 years	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).
Readmission	up to 3 years	Reintervention (reirradiation, surgery, other); Development of neurological symptoms; Development of pathologic fracture

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands