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Post-operative RadioTherapy for Patients With Metastases of the Long Bones (PORT)

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ClinicalTrials.gov Identifier: NCT02705183
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 of cancer, 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. One of the debatable issues is the effectiveness of postoperative radiotherapy. It has become common practise due to professional opinion, but research evidence is lacking. It is thought that adjuvant radiotherapy improves the durability of an implant, prevents progression of the lesion, promotes bone healing, improves limb function, minimises pain and reduces the need for reoperations, however none of these are certain. Moreover, it is a burden on patient's quality of life (e.g. multiple extra hospital visits) causing toxicity and possible side effects (e.g. skin irritation). The true beneficial effect, weighing up the possible pros and certain cons, of adjuvant radiotherapy is thus unknown.

Objective: The PORT study aims to demonstrate the non-inferiority of 'surgery only' compared to surgery with adjuvant radiotherapy as treatment of impending and actual pathological fractures on the pain experienced by patients.

Study design: A multicentre, prospective, randomised non-inferiority trial nested within the OPTIMAL study.

Study population: All patients with metastases of the long bones undergoing surgery for a(n) (impending) pathologic fracture in the participating centres.

Study intervention: One study arm (A) will receive surgery with adjuvant radiotherapy; the other study arm (B) will receive surgery only.

Main study parameters/endpoints: Primary endpoint is patient reported pain according to a numeric rating scale (NRS). Clinical functioning, radiological status, complications and survival are secondary endpoints.


Condition or disease Intervention/treatment Phase
Metastasis to Bone Radiation: Radiotherapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-operative RadioTherapy for Patients With Metastases of the Long Bones: a Randomised Controlled Trial
Study Start Date : January 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
Active Comparator: A: Surgery & Post-operative radiotherapy
Surgery & Post-operative radiotherapy
Radiation: Radiotherapy
Multifractionated post-operative radiotherapy, several weeks after surgery

No Intervention: B: Surgery only
Surgery only



Primary Outcome Measures :
  1. The number of patients with a difference of 2 points or more on a 11-point numeric rating scale for pain [ Time Frame: 3 months ]
    Pain will measured before treatment and after treatment on an 11-point numeric rating scale for pain. If the score differs more than 2 points between those measuring moments the change in pain is reported as significant. The number of patients in each group with a significant change in pain score will be measured.


Secondary Outcome Measures :
  1. Complications [ Time Frame: 3 months, 6 months, 1 year ]
    Complications such as loosening of implant



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 or older
  • Bone metastasis deriving from the following bones:

    • humerus, ulna, radius
    • femur, tibia, fibula
  • 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)
  • Receive surgical treatment with palliative intent for a pathologic fracture or impending pathologic fracture

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)
  • Lesions in the small bones of the extremities
  • (Surgical) treatment with curative intent

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): NCT02705183


Contacts
Contact: Julie 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: NCT02705183     History of Changes
Other Study ID Numbers: NL54480.058.15
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:
surgical treatment
post-operative radiotherapy
quality of life
complications
survival
long bones

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes