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

Vertebral Bony Metastases Clinical Trial

— IRON-2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02832765
• Other study ID #: IRON-2
• Status: Not yet recruiting
• Phase: Phase 2
• First received: July 12, 2016
• Last updated: July 12, 2016
• Start date: September 2016
• Est. completion date: February 2018

Study information

• Verified date: July 2016
• Source: Heidelberg University
• Contact: Harald Rief, MD, PhD
• Email: harald.rief[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: University of Heidelberg, Germany: Ethics committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms, Second Primary
• Vertebral Bony Metastases

Intervention

Radiation:
• A
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 of the involved spinal bone metastases
• C
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 of the involved spinal bone metastases

Locations

Country	Name	City	State
Germany	Dept of Radiation Oncology, University of Heidelberg, Germany	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Chung Y, Yoon HI, Kim JH, Nam KC, Koom WS. Is helical tomotherapy accurate and safe enough for spine stereotactic body radiotherapy? J Cancer Res Clin Oncol. 2013 Feb;139(2):243-8. doi: 10.1007/s00432-012-1321-0. Epub 2012 Oct 2. — View Citation

Guckenberger M, Sweeney RA, Flickinger JC, Gerszten PC, Kersh R, Sheehan J, Sahgal A. Clinical practice of image-guided spine radiosurgery--results from an international research consortium. Radiat Oncol. 2011 Dec 15;6:172. doi: 10.1186/1748-717X-6-172. — View Citation

Katsoulakis E, Riaz N, Cox B, Mechalakos J, Zatcky J, Bilsky M, Yamada Y. Delivering a third course of radiation to spine metastases using image-guided, intensity-modulated radiation therapy. J Neurosurg Spine. 2013 Jan;18(1):63-8. doi: 10.3171/2012.9.SPI — View Citation

Ryu S, Pugh SL, Gerszten PC, Yin FF, Timmerman RD, Hitchcock YJ, Movsas B, Kanner AA, Berk LB, Followill DS, Kachnic LA. RTOG 0631 phase 2/3 study of image guided stereotactic radiosurgery for localized (1-3) spine metastases: phase 2 results. Pract Radia — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local control	local control as bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine	3 months after RT	Yes
Secondary	progression-free survival (PFS)	PFS is assessed 2 years post completion of radiotherapy	2 years post completion of radiotherapy	No
Secondary	pain reduction	pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation	end of treatment, 12 and 24 weeks post completion of radiotherapy	No
Secondary	Quality of life	Quality of life is assessed using the EORTC BM22 questionnaire at 12 and 24 weeks post completion of treatment	12 and 24 weeks post completion of therapy	No
Secondary	Fatigue	Fatigue is assessed using the EORTC FA13 questionnaire	12 and 24 weeks post completion of therapy	No