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Intensity-modulated Radiotherapy With Integrated-boost in Patients With Spinal Bone Metastases (IRON-2)

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ClinicalTrials.gov Identifier: NCT02832765
Recruitment Status : Unknown
Verified July 2016 by Heidelberg University.
Recruitment status was:  Not yet recruiting
First Posted : July 14, 2016
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Vertebral Bony Metastases Radiation: A Radiation: B Radiation: C Radiation: D Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensity-modulated Radiotherapy With Integrated-boost in Patients With Spinal Bone Metastases
Study Start Date : September 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: A
Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions
Radiation: A
Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions of the involved spinal bone metastases

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

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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. progression-free survival (PFS) [ Time Frame: 2 years post completion of radiotherapy ]
    PFS is assessed 2 years post completion of radiotherapy

  2. 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

  3. 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

  4. Fatigue [ Time Frame: 12 and 24 weeks post completion of therapy ]
    Fatigue is assessed using the EORTC FA13 questionnaire



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02832765


Contacts
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Contact: Harald Rief, MD, PhD harald.rief@med.uni-heidelberg.de
Contact: Jürgen Debus, MD, PhD juergen.debus@med.uni-heidelberg.de

Locations
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Germany
Dept of Radiation Oncology, University of Heidelberg, Germany
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Heidelberg University
ClinicalTrials.gov Identifier: NCT02832765     History of Changes
Other Study ID Numbers: IRON-2
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Heidelberg University:
Palliative radiotherapy
Bone metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes