Fractionated Radiosurgery for Painful Spinal Metastases

NCT01594892 | Completed DMC

• 1 other identifier: DOSIS
• Study Type: interventional
• Target: 60
• Locations: 4 countries
• Sites: 5

Brief 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.

Conditions

Neoplasm Metastasis; Neoplastic Processes; Neoplasm Recurrence, Local; Neoplasm, Residual; Pain

Keywords

Spinal metastases; Vertebral metastases; Radiosurgery; Radiotherapy; Stereotactic body radiotherapy; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Local tumor control

  2 years

• Local tumor control

  2 years

• Overall survival

  2 years

• Patient-assessed 5 dimensions of patient's quality-of-life

  Changes in quality of life from baseline to 3 months post-treatment

• Patient-assessed overall health status

  Changes in quality of life from baseline to 3 months post-treatment

Study Arms (1)

Dose intensified SBRT

EXPERIMENTAL

Depending on the modified Mizumoto Score (0-4 points or 5-9 points) patients 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 or with 5 fractions of 7Gy in involved parts of the vertebra and 4Gy in not-involved parts using a simultaneous integrated boost, respectively.

Radiation: Radiosurgery

Interventions

Radiosurgery RADIATION

Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery

Dose intensified SBRT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• Royal Marsden NHS Foundation Trust: collaborator

Study Sites (5)

Leopoldina Schweinfurt

Schweinfurt, Germany

Location

Department of Radiation Oncology, University of Wuerzburg

Würzburg, 97080, Germany

Location

Netherlands Cancer Institute

Amsterdam, Netherlands

Location

University Hospital Zurich

Zurich, Switzerland

Location

The Royal Marsden Hospital NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 23164174 BACKGROUND

• 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. Cancer. 2018 May 1;124(9):2001-2009. doi: 10.1002/cncr.31294. Epub 2018 Mar 2.

  PMID: 29499073 RESULT

• Mantel F, Sweeney RA, Klement RJ, Hawkins MA, Belderbos J, Ahmed M, Toussaint A, Polat B, Flentje M, Guckenberger M. Risk factors for vertebral compression fracture after spine stereotactic body radiation therapy: Long-term results of a prospective phase 2 study. Radiother Oncol. 2019 Dec;141:62-66. doi: 10.1016/j.radonc.2019.08.026. Epub 2019 Sep 13.

  PMID: 31526672 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplastic Processes; Neoplasm Recurrence, Local; Neoplasm, Residual; Pain

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Matthias Guckenberger, MD

  Department of Radiation Oncology, University of Wuerzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Evaluation of the single intervention - dose-intensified SBRT

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 9, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2017
• Last Updated: September 4, 2019

Record last verified: 2019-08

Locations

CH (1); DE (2); NL (1); GB (1)