Fractionated Radiosurgery for Painful Spinal Metastases

Pain Clinical Trial

— DOSIS  

Official title:

Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594892
• Other study ID #: DOSIS
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: July 2017

Study information

• Verified date: August 2019
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is the study hypothesis that hypo-fractionated image-guided radiosurgery significantly improves pain relief compared to historic data of conventionally fractionated radiotherapy. Primary endpoint is pain response 3 months after radiosurgery, which is defined as pain reduction of ≥2 points at the treated vertebral site on the 0 to 10 Visual Analogue Scale. 60 patients will be included into this II trial.

Description:

The current study will investigate efficacy and safety of radiosurgery for painful vertebral metastases and three characteristics will distinguish this study.

1. A prognostic score for overall survival will be used for selection of patients with longer life expectancy to allow for analysis of long-term efficacy and safety.

2. Fractionated radiosurgery will be performed with the number of treatment fractions adjusted to either good (10 fractions) or intermediate (5 fractions) life expectancy. Fractionation will allow inclusion of tumors immediately abutting the spinal cord due to higher biological effective doses at the tumor - spinal cord interface compared to single fraction treatment.

3. Dose intensification will be performed in the involved parts of the vertebrae only, while uninvolved parts are treated with conventional doses using the simultaneous integrated boost concept.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Established histological diagnosis of a malignant tumour (primary or metastatic)

2. Vertebral metastasis confirmed via biopsy or radiology

3. Pain in the involved spinal region or free of pain under pain medication

4. Fully consenting patients, >18 years old

5. Karnofsky Performance Index =60%

6. Good or intermediate life expectancy according to the modified prognostic Mizumoto Score (score = 9)

7. Patient must be able to tolerate fixation systems and 30 minutes treatment time

8. Discussed in interdisciplinary tumour board

9. The following types of spinal tumours are eligible:

• Recurrent / residual tumours after surgery

• Tumours in medically inoperable patients or patients deemed inoperable due to limited life expectancy / tumour load

• Lesions associated with significant surgical risk

Exclusion Criteria:

1. Short life expectancy according to the modified Mizumoto Sore

2. "Radiosensitive" histologies (i.e. lymphoma, SCLC, multiple myeloma)

3. Non-ambulatory status

4. Progressive neurological symptoms/deficit

5. > 3 involved vertebral levels

6. > 2 treatment sites

7. Spine instability

8. Previous radiotherapy at the involved levels

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasm Recurrence, Local
• Neoplasm, Residual
• Neoplasms
• Neoplasms, Second Primary
• Neoplastic Processes
• Pain
• Recurrence

Intervention

Radiation:
• Radiosurgery
Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery

Locations

Country	Name	City	State
Germany	Leopoldina Schweinfurt	Schweinfurt
Germany	Department of Radiation Oncology, University of Wuerzburg	Wuerzburg
Netherlands	Netherlands Cancer Institute	Amsterdam
Switzerland	University Hospital Zurich	Zurich
United Kingdom	The Royal Marsden Hospital NHS Foundation Trust	Sutton

Sponsors (2)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	Royal Marsden NHS Foundation Trust

Countries where clinical trial is conducted

Germany,  Netherlands,  Switzerland,  United Kingdom, 

References & Publications (2)

Guckenberger M, Hawkins M, Flentje M, Sweeney RA. Fractionated radiosurgery for painful spinal metastases: DOSIS - a phase II trial. BMC Cancer. 2012 Nov 19;12:530. doi: 10.1186/1471-2407-12-530. — View Citation

Guckenberger M, Sweeney RA, Hawkins M, Belderbos J, Andratschke N, Ahmed M, Madani I, Mantel F, Steigerwald S, Flentje M. Dose-intensified hypofractionated stereotactic body radiation therapy for painful spinal metastases: Results of a phase 2 study. Canc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients, in whom pain is decreased in response to treatment	Decrease in pain by =2 points at the treated vertebral site on the 0 (no pain) to 10 (the severest pain) Visual Analogue Scale without analgesic increase	Change in pain from baseline to 3 months post-treatment
Secondary	Local tumor control	At the treated vertebral levels assessed with MRI	2 years
Secondary	Local tumor control	At the treated vertebral levels assessed with CT imaging	2 years
Secondary	Overall survival	Death from any cause	2 years
Secondary	Patient-assessed 5 dimensions of patient's quality-of-life	Measured with the 5-level (no problems, slight problems, moderate problems, severe problems, and extreme problems) EuroQol 5-Dimension Questionnaire (EQ-5D) questionnaire	Changes in quality of life from baseline to 3 months post-treatment
Secondary	Patient-assessed overall health status	Measured with the EuroQol Visual Analog Scale from 0 ("the worst health you can imagine") to 100 (the best health you can imagine")	Changes in quality of life from baseline to 3 months post-treatment
Secondary	Number of patients developing acute toxicity	Measured with NCI CTCAE v 4.0	Changes from baseline up to 6 weeks post-treatment
Secondary	Number of patients developing late toxicity	Measured with NCI CTCAE v 4.0	Changes from >6weeks up to 2 years post-treatment