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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: A: Surgery & Post-operative radiotherapy
Surgery & Post-operative radiotherapy
Multifractionated post-operative radiotherapy, several weeks after surgery
No Intervention: B: Surgery only
- 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.
- Complications [ Time Frame: 3 months, 6 months, 1 year ]Complications such as loosening of implant
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
|Contact: Julie Willeumier, MD||+31 71 526 email@example.com|
|Contact: Gerco van der Wal, MD||+31 71 526 firstname.lastname@example.org|
|Leiden University Medical Center||Recruiting|
|Leiden, Netherlands, 2333ZA|
|Contact: Sander Dijkstra, MD PhD +31 71 526 3606 email@example.com|
|Contact: Yvette van der Linden, MD PhD +31 71 5265539 firstname.lastname@example.org|
|Principal Investigator:||Sander Dijkstra, MD PhD||Leiden University Medical Center|
|Principal Investigator:||Yvette van der Linden, MD PhD||Leiden University Medical Center|