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

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ClinicalTrials.gov Identifier: NCT02705157
Recruitment Status : Recruiting
First Posted : March 10, 2016
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
PD Sander Dijkstra, MD PhD, Leiden University Medical Center

Brief 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.


Condition or disease Intervention/treatment
Bone Metastasis Procedure: Stabilisation of (impending) pathological fracture Radiation: Radiotherapy of bone metastasis

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The OPTIMAL Study - A Prospective Cohort of Patients With Bone Metastases of the Long Bones
Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2021

Group/Cohort Intervention/treatment
Bone metastasis of the long bone
Patients with bone metastases of the long bone(s) receiving surgical stabilisation of a pathologic or impending fracture or receiving radiotherapy for a painful metastasis.
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




Primary Outcome Measures :
  1. Change in quality of life before and after treatment as measured by EQ-5D, EORTC BM-22, and EORTC PAL-15. [ Time Frame: 4 weeks, 8 weeks, 3 months, 6 months, 12 months, 18 months, 24 months after treatment ]
    The influence on the quality of life of a treatment will be measured by several patient reported outcome scores (EQ-5D, EORTC BM-22, and EORTC PAL-15) at several time points after treatment. These will be used to calculate the changes shortly and longer after treatment.

  2. Change in pain before and after treatment as measured by an 11-point numeric rating scale (NRS) [ Time Frame: 4 weeks, 8 weeks, 3 months, 6 months, 12 months, 18 months, 24 months after treatment ]
    The influence of a treatment on the pain will be measured by a reported outcome score (NRS) at several time points after treatment. These will be used to calculate the changes shortly and longer after treatment.

  3. Change in function before and after treatment as measured by the Toronto Extremity Salvage Score (TESS). [ Time Frame: 4 weeks, 8 weeks, 3 months, 6 months, 12 months, 18 months, 24 months after treatment ]
    The influence of a treatment on the function will be measured by a patient reported outcome scores (TESS) at several time points after treatment. These will be used to calculate the changes shortly and longer after treatment.


Secondary Outcome Measures :
  1. Proportion of participants with overall survival at 6 months [ Time Frame: 6 months ]
  2. Proportion of participants with overall survival at 1 year [ Time Frame: 1 year ]
  3. Proportion of participants with overall survival at 2 years [ Time Frame: 2 years ]
  4. Number of patients with complications as reported by physicians [ Time Frame: 8 weeks ]
    For complication rate, the Henderson classification of complications will be applied. This classification identifies five primary modes of endoprosthetic failure: soft tissue failure (type 1), aseptic loosening (type 2), structural failure (type 3), infection (type 4), and tumour progression (type 5). Wound complications with clinical consequences will be registered separately. Re-operations due to complications will be registered as such in the treatment field as a new operation.

  5. Number of patients with complications as reported by physicians [ Time Frame: 6 months ]
    For complication rate, the Henderson classification of complications will be applied. This classification identifies five primary modes of endoprosthetic failure: soft tissue failure (type 1), aseptic loosening (type 2), structural failure (type 3), infection (type 4), and tumour progression (type 5). Wound complications with clinical consequences will be registered separately. Re-operations due to complications will be registered as such in the treatment field as a new operation.

  6. Number of patients with complications as reported by physicians [ Time Frame: 1 year ]
    For complication rate, the Henderson classification of complications will be applied. This classification identifies five primary modes of endoprosthetic failure: soft tissue failure (type 1), aseptic loosening (type 2), structural failure (type 3), infection (type 4), and tumour progression (type 5). Wound complications with clinical consequences will be registered separately. Re-operations due to complications will be registered as such in the treatment field as a new operation.

  7. Number of patients with complications as reported by physicians [ Time Frame: 2 years ]
    For complication rate, the Henderson classification of complications will be applied. This classification identifies five primary modes of endoprosthetic failure: soft tissue failure (type 1), aseptic loosening (type 2), structural failure (type 3), infection (type 4), and tumour progression (type 5). Wound complications with clinical consequences will be registered separately. Re-operations due to complications will be registered as such in the treatment field as a new operation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients visiting the radiation oncologist or the orthopaedic surgeon of participating centres, for possible local treatment of a symptomatic BMLB or impending fracture, will be registered in the OPTIMAL registry. This includes patients with newly diagnosed metastatic bone disease as well as patients undergoing re-treatment of the same lesion or patients who have received previous treatment for other lesions. Preferably patients are included before the start of treatment, but inclusion can also take place during treatment. When patients are already included in the cohort (for treatment of another metastasis), they will not be included a second time when they present with a second lesion of the long bones. This second lesion will be registered under the same patient number.
Criteria

Inclusion Criteria:

  • Aged 18 or older
  • Radiographic or histologic proof of metastatic bone disease
  • Histologic diagnosis of the primary tumour or - if the diagnosis is unknown - at least adequate diagnostic investigations into the origin of the metastasis (e.g. dissemination imaging, histology, biopsy)
  • Bone metastasis deriving from the bones of the extremities

Exclusion Criteria:

  • Primary bone tumours (benign and/or malignant)
  • No informed consent signed
  • Communication with patient is hampered (e.g. language barrier, severe cognitive impairment, dementia)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705157


Contacts
Contact: Julie J Willeumier, MD +31 71 526 3606 j.j.willeumier@lumc.nl
Contact: Gerco van der Wal, MD +31 71 526 3606 c.w.p.g.van_der_wal@lumc.nl

Locations
Netherlands
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2333ZA
Contact: Sander Dijkstra, MD PhD    +31 71 526 3606    p.d.s.dijkstra@lumc.nl   
Contact: Yvette van der Linden, MD PhD    +31 71 5265539    y.m.van_der_linden@lumc.nl   
Sponsors and Collaborators
Leiden University Medical Center
Investigators
Principal Investigator: Sander Dijkstra, MD PhD Leiden University Medical Center
Principal Investigator: Yvette van der Linden, MD PhD Leiden University Medical Center

Additional Information:
Responsible Party: PD Sander Dijkstra, MD PhD, MD PhD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT02705157     History of Changes
Other Study ID Numbers: NL54439.058.15
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by PD Sander Dijkstra, MD PhD, Leiden University Medical Center:
long bones
survival
prognosis
treatment
quality of life

Additional relevant MeSH terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases