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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vertebral Bony Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions

Group Type EXPERIMENTAL

A

Intervention Type RADIATION

Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions of the involved spinal bone metastases

B

Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions with an SIB with 40 Gy in 10 fractions to the metastasis

Group Type EXPERIMENTAL

B

Intervention Type RADIATION

Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions with an SIB with 40 Gy in 10 fractions to the metastasis of the involved spinal bone metastases

C

Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions

Group Type EXPERIMENTAL

C

Intervention Type RADIATION

Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions of the involved spinal bone metastases

D

Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions with an SIB with 30 Gy in 5 fractions to the metastasis

Group Type EXPERIMENTAL

D

Intervention Type RADIATION

Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions with an SIB with 30 Gy in 5 fractions to the metastasis of the involved spinal bone metastases

Interventions

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A

Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions of the involved spinal bone metastases

Intervention Type RADIATION

B

Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions with an SIB with 40 Gy in 10 fractions to the metastasis of the involved spinal bone metastases

Intervention Type RADIATION

C

Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions of the involved spinal bone metastases

Intervention Type RADIATION

D

Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions with an SIB with 30 Gy in 5 fractions to the metastasis of the involved spinal bone metastases

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No