Fractionated Radiosurgery for Painful Spinal Metastases (DOSIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Wuerzburg University Hospital
Sponsor:
Collaborator:
Royal Marsden NHS Foundation Trust
Information provided by (Responsible Party):
Wuerzburg University Hospital
ClinicalTrials.gov Identifier:
NCT01594892
First received: May 7, 2012
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Neoplasm Metastasis
Neoplastic Processes
Neoplasm Recurrence, Local
Neoplasm, Residual
Pain
Radiation: Radiosurgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)

Resource links provided by NLM:


Further study details as provided by Wuerzburg University Hospital:

Primary Outcome Measures:
  • Pain response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Pain response 3 months after radiosurgery defined as pain reduction of ≥2 points at the treated vertebral site on the 0 to 10 Visual Analogue Scale without analgesic increase will be defined as pain response


Secondary Outcome Measures:
  • Local tumor control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Local tumor control at the treated vertebral levels and regional tumor control at the neighbouring vertebrae assessed in MRI and CT imaging

  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cancer specific mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Quality of life using the EQ-5D and EORTC QLQ-BM22

  • Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Acute and late toxicity according to NCI CTCAE v 4.0


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Long life expectancy
Patients with long life expectancy based on the modified Mizumoto Score (0-4 points) will be treated with 10 fractions of 4.85Gy in involved parts of the vertebra and 3Gy in not-involved parts using a simultaneous integrated boost
Radiation: Radiosurgery
Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery
Experimental: B: intermediate life expectancy
Patients with intermediate life expectancy based on the modified Mizumoto Score (5-9 points) will be treated with 5 fractions of 7Gy in involved parts of the vertebra and 4Gy in not-involved parts using a simultaneous integrated boost
Radiation: Radiosurgery
Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery

Detailed 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.
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594892

Contacts
Contact: Matthias Guckenberger, MD +49 931 201 28984 Guckenberger_m@klinik.uni-wuerzburg.de

Locations
Germany
Department of Radiation Oncology, University of Wuerzburg Recruiting
Wuerzburg, Germany, 97080
Contact: Matthias Guckenberger, MD    +49 931 201 28984    Guckenberger_m@klinik.uni-wuerzburg.de   
Principal Investigator: Matthias Guckenberger, MD         
Sub-Investigator: Reinhart A Sweeney, MD         
United Kingdom
The Royal Marsden Hospital NHS Foundation Trust Not yet recruiting
Sutton, United Kingdom, SM2 5PT
Principal Investigator: Maria Hawkins, MD         
Sponsors and Collaborators
Wuerzburg University Hospital
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Matthias Guckenberger, MD Department of Radiation Oncology, University of Wuerzburg
  More Information

No publications provided by Wuerzburg University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT01594892     History of Changes
Other Study ID Numbers: DOSIS
Study First Received: May 7, 2012
Last Updated: July 10, 2012
Health Authority: Germany: The Bavarian State Ministry of the Environment and Public Health

Keywords provided by Wuerzburg University Hospital:
Spinal metastases
Vertebral metastases
Radiosurgery
Radiotherapy
Stereotactic body radiotherapy
Pain

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Recurrence
Neoplasm Recurrence, Local
Neoplastic Processes
Neoplasm, Residual
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on September 18, 2014