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

Phase 2

• Conditions: Vertebral Bony Metastases
• Interventions: Radiation: A; Radiation: D; Radiation: B; Radiation: C

• Registration Number: NCT02832765
• Lead Sponsor: Heidelberg University

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 Description

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.

Study Timeline

• Status Verified: 2016-07
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-12
• Last Update Submitted: 2016-07-12
• Study First Posted: 2016-07-14
• Last Update Posted: 2016-07-14
• Study Start: 2016-09
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients with a histologically confirmed tumor diagnosis, with secondarily diagnosed solitary/multiple metastatic spinal bone metastases
• Indication for RT of the bone metastasis
• Age: between 18 and 80 years
• Karnofsky performance score ≥ 70
• Signed Declaration of Informed Consent
• Bisphosphonate therapy

Exclusion Criteria

• Significant neurological or psychiatric disorders, including dementia and epileptic seizures
• Lacking or diminished legal capacity
• foregoing radiotherapy in the planned RT area
• Any medical of psychological condition that the study director considers a preventive factor for the patient's ability to complete the study or to adequately understand the scope of the study and to give his/her consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
A	A	Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions
D	D	Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions with an SIB with 30 Gy in 5 fractions to the metastasis
B	B	Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions with an SIB with 40 Gy in 10 fractions to the metastasis
C	C	Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions

Primary Outcome Measures

Name	Time	Method
local control	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

Secondary Outcome Measures

Name	Time	Method
Fatigue	12 and 24 weeks post completion of therapy	Fatigue is assessed using the EORTC FA13 questionnaire
progression-free survival (PFS)	2 years post completion of radiotherapy	PFS is assessed 2 years post completion of radiotherapy
pain reduction	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	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

Trial Locations

Locations (1)

Dept of Radiation Oncology, University of Heidelberg, Germany; 🇩🇪 Heidelberg, Germany