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The OPTIMAL Study - A Prospective Cohort of Patients With Bone Metastases of the Long Bones

NCT02705157 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2016-09-19

No results posted yet for this study

Summary

Rationale: Bone metastases arise in 50% of all patients dying from carcinoma, increasing up to 70% in patients with breast and prostate cancer. The lesions can cause pain and fractures, leading to diminished quality of life and poorer survival. Current knowledge concerning adequate, personalized treatment of metastatic lesions of the long bones in patients with disseminated cancer is insufficient and inconclusive due to lack of large, prospective series with patient reported outcome measures.

Objective: The OPTIMAL cohort aims to describe the quality of life and pain perception of patients after local treatment (radiotherapy and/or surgery) of metastases of the long bones, for both the entire cohort as well as for specific treatments separately. With this a more personalized treatment for metastases in the long bones based on expected survival and impending fracture risk can be provided in order to improve functioning and the quality of life for the remaining lifetime in patients with disseminated cancer.

Study design: Observational, prospective, multicentre cohort study.

Study population: All patients with metastases of the long bones visiting a radiation oncologist or orthopaedic surgeon.

Main study parameters/endpoints: Primary endpoints are patient reported quality of life (including functioning) and pain levels. Complications and survival are secondary endpoints.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in the OPTIMAL cohort will perhaps not directly benefit from their participation. Participation will contribute to deriving patient-specific treatment modalities for future patients with bone metastases of the long bones. Risks associated with participation in the prospective cohort are considered negligible due to the observational nature of the study. The burden for the patients lies in completion of questionnaires, which is considered to be in proportion with the potential value of this research.

Conditions

  • Bone Metastasis

Interventions

PROCEDURE

Stabilisation of (impending) pathological fracture

Stabilisation of pathological fracture or impending fracture with prosthesis, plate, intramedullary nail, cement, or other stabilisation method

RADIATION

Radiotherapy of bone metastasis

Radiotherapy of bone metastasis, single or multi-fractionated

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Sander Dijkstra, MD PhD · Leiden University Medical Center

  • Yvette van der Linden, MD PhD · Leiden University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-01-31
Completion
2021-01-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02705157 on ClinicalTrials.gov