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

NCT02705157 | Unknown

• 1 other identifier: NL54439.058.15
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Metastasis

Keywords

long bones; survival; prognosis; treatment; quality of life

Outcome Measures

Primary Outcomes (3)

• Change in quality of life before and after treatment as measured by EQ-5D, EORTC BM-22, and EORTC PAL-15.

  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.

  4 weeks, 8 weeks, 3 months, 6 months, 12 months, 18 months, 24 months after treatment

• Change in pain before and after treatment as measured by an 11-point numeric rating scale (NRS)

  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.

  4 weeks, 8 weeks, 3 months, 6 months, 12 months, 18 months, 24 months after treatment

• Change in function before and after treatment as measured by the Toronto Extremity Salvage Score (TESS).

  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.

  4 weeks, 8 weeks, 3 months, 6 months, 12 months, 18 months, 24 months after treatment

Secondary Outcomes (7)

• Proportion of participants with overall survival at 6 months

  6 months

• Proportion of participants with overall survival at 1 year

  1 year

• Proportion of participants with overall survival at 2 years

  2 years

• Number of patients with complications as reported by physicians

  8 weeks

• Number of patients with complications as reported by physicians

  6 months

Study Arms (1)

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; Radiation: Radiotherapy of bone metastasis

Interventions

Stabilisation of (impending) pathological fracture PROCEDURE

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

Bone metastasis of the long bone

Radiotherapy of bone metastasis RADIATION

Radiotherapy of bone metastasis, single or multi-fractionated

Bone metastasis of the long bone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, 2333ZA, Netherlands

RECRUITING

Related Links

• Website of OPTIMAL Study

Study Officials

• Sander Dijkstra, MD PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

• Yvette van der Linden, MD PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie J Willeumier, MD

CONTACT

+31 71 526 3606; j.j.willeumier@lumc.nl

Gerco van der Wal, MD

CONTACT

+31 71 526 3606; c.w.p.g.van_der_wal@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 10, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2021
• Last Updated: September 19, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)