Clinical Trial: Intensity-modulated Radiotherapy With Integrated-boost in Patients With Spinal Bone Metastases

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Intensity-modulated Radiotherapy With Integrated-boost in Patients With Spinal Bone Metastases

Brief Summary: The primary goal of the study is to determine the local control-rate after radiotherapy (RT) with and without simultaneous integrated boost (SIB) concepts in patients with bone metastases of the spine. Further study objectives are survival, and clinical parameters such as pain, quality of life (QoL) and fatigue. We expect an improvement in local control and consecutively an increased re-sclerotization of the bone metastasis due to a higher biological dose in the tumor area. Therefore patients could benefit in quality-of-life, pain relief and mobility.

Detailed Summary: The vertebral column is the main localization of bone metastases and is where they frequently indicate an advanced stage of a malignant primary disease [1, 2]. Two thirds of all patients with tumors are estimated to develop bone metastases in the course of their disease [3]. Spinal bone metastases are of central impact for patients in a palliative setting. The clinical symptoms include pain at rest and under exercise but also impaired activity of daily life, the risk of pathological fractures, and neurological deficits. Local control is the essential factor for stability of the vertebral body of patients with spinal bone metastases. In regard to re-calcification of former osteolytic lesions, palliative radiotherapy (RT) represents an effective treatment option [4]. The most common schedule was specified as 30 Gy in 10 fractions. Stereotactic body radiation therapy (SBRT) using intensity-modulated radiotherapy (IMRT) can be a safe modality for treating spinal metastasis with enhanced targeting accuracy [5]. Secondly, IMRT to the spine was well tolerated (especially in the spinal cord), had no significant late toxicities, and spared other organs at risk simultaneously [6]. The main problem of the standard schedule is the limited dose application to the metastasis due to organ at risk myelon. Therefore, the aims of this study is to apply a high biological dose in the tumor region and to achieve an improved result related to local control for palliative patients with painful spinal bone metastases. Secondly, the aim is to evaluate QoL, fatigue, and survival of three different RT-techniques. To the best of our knowledge, no comparable randomized study has been described in the literature so far.
Sponsor: Heidelberg University

Current Primary Outcome: local control [ Time Frame: 3 months after RT ]

local control as bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • progression-free survival (PFS) [ Time Frame: 2 years post completion of radiotherapy ]
    PFS is assessed 2 years post completion of radiotherapy
  • pain reduction [ Time Frame: end of treatment, 12 and 24 weeks post completion of radiotherapy ]
    pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation
  • Quality of life [ Time Frame: 12 and 24 weeks post completion of therapy ]
    Quality of life is assessed using the EORTC BM22 questionnaire at 12 and 24 weeks post completion of treatment
  • Fatigue [ Time Frame: 12 and 24 weeks post completion of therapy ]
    Fatigue is assessed using the EORTC FA13 questionnaire


Original Secondary Outcome: Same as current

Information By: Heidelberg University

Dates:
Date Received: July 12, 2016
Date Started: September 2016
Date Completion: February 2018
Last Updated: July 12, 2016
Last Verified: July 2016