Post-operative RadioTherapy for Patients With Metastases of the Long Bones: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- The number of patients with a difference of 2 points or more on a 11-point numeric rating scale for pain
研究概览
简要总结
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.
详细描述
The PORT study aims to demonstrate the non-inferiority of 'surgery only' compared to 'surgery with adjuvant radiotherapy' for the fixation of impending and actual pathological fractures of the long bones. We hypothesize that patients without post-operative radiotherapy will not have more pain than those receiving post-operative radiotherapy. The primary efficacy endpoint will be the pain level (as measured by an eleven point numeric rating scale (NRS)) 12 weeks after treatment. Pain has been chosen as primary endpoint because it can be interpreted as a "proxy" for mechanical loosening or other complications. It was undesirable to select revision surgery as endpoint, because the number of revision surgeries will be very low in this patient population. A revision will only be performed for serious complications with large effects on the quality of life. In other cases, conservative options will be chosen over revision surgery.
Secondary endpoints are complications, quality of life and overall survival.
A secondary objective is to conduct cost-effectiveness and costs-utility analyses.
This study is a multicentre, prospective, randomised non-inferiority trial nested within the OPTIMAL study. The OPTIMAL study is the backbone of the (OPTIMAL-) PORT study, encompassing the prospective cohort and providing the infrastructure for collection patient reported outcome measures. If patients do not have an indication for surgery, they can only be included in the OPTIMAL study. If patients have an indication for surgery, they are recruited for the OPTIMAL-PORT study. However, if patients do not give consent for randomisation for radiotherapy, they can give partial consent and participate in the prospective cohort and complete questionnaires. This data will contribute to the OPTIMAL study. Details concerning the OPTIMAL study are described in the respective protocol.
The PORT trial is a non-inferiority trial between ' surgery with post-operative radiotherapy' (Arm A) with 'surgery only (no post-operative radiotherapy)' (Arm B). A non-inferiority design is appropriate for this study because we expect that the clinical outcomes with surgery only are not worse than with post-operative radiotherapy. 'Surgery only' however has evident advantages, as it will lessen the burden on patients of visiting the hospital, prevent toxicity and cost less. Furthermore, as mentioned in the introduction, the focus of treatment is on maintaining and improving quality of life. The goal is to do what is right, safe, and efficient and not to provide more care than is needed. Rethinking whether we need post-operative radiotherapy is part of achieving that goal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The number of patients with a difference of 2 points or more on a 11-point numeric rating scale for pain
时间窗: 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.
次要结局
- Complications(3 months, 6 months, 1 year)
研究者
PD Sander Dijkstra, MD PhD
MD PhD
Leiden University Medical Center