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

NCT02705183 | Unknown

• 1 other identifier: NL54480.058.15
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastasis to Bone

Keywords

surgical treatment; post-operative radiotherapy; quality of life; complications; survival; long bones

Outcome Measures

Primary Outcomes (1)

• The number of patients with a difference of 2 points or more on a 11-point numeric rating scale for pain

  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.

  3 months

Secondary Outcomes (1)

• Complications

  3 months, 6 months, 1 year

Study Arms (2)

A: Surgery & Post-operative radiotherapy

ACTIVE COMPARATOR

Surgery \& Post-operative radiotherapy

Radiation: Radiotherapy

B: Surgery only

NO INTERVENTION

Surgery only

Interventions

Radiotherapy RADIATION

Multifractionated post-operative radiotherapy, several weeks after surgery

A: Surgery & Post-operative radiotherapy

Eligibility Criteria

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

You may qualify if:

• 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

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

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, 2333ZA, Netherlands

RECRUITING

Related Links

• Website of OPTIMAL Study, including PORT study

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

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 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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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, 2019
• Study Completion: January 1, 2019
• Last Updated: September 19, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)