Fractionated Radiosurgery for Painful Spinal Metastases (DOSIS)
This study is currently recruiting participants.
Verified July 2012 by Wuerzburg University Hospital
Sponsor:
Wuerzburg University Hospital
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
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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.
- 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.
- 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.
- 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:
- Established histological diagnosis of a malignant tumour (primary or metastatic)
- Vertebral metastasis confirmed via biopsy or radiology
- Pain in the involved spinal region or free of pain under pain medication
- Fully consenting patients, >18 years old
- Karnofsky Performance Index ≥60%
- Good or intermediate life expectancy according to the modified prognostic Mizumoto Score (score ≤ 9)
- Patient must be able to tolerate fixation systems and 30 minutes treatment time
- Discussed in interdisciplinary tumour board
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:
- Short life expectancy according to the modified Mizumoto Sore
- "Radiosensitive" histologies (i.e. lymphoma, SCLC, multiple myeloma)
- Non-ambulatory status
- Progressive neurological symptoms/deficit
- > 3 involved vertebral levels
- > 2 treatment sites
- Spine instability
- Previous radiotherapy at the involved levels
Contacts and Locations
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 Neoplasm Recurrence, Local Neoplastic Processes |
Recurrence Neoplasm, Residual Pathologic Processes Disease Attributes |
ClinicalTrials.gov processed this record on May 23, 2013