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Completed

NCT Number: NCT01594892

Fractionated Radiosurgery for Painful Spinal Metastases

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.

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Key information

Conditions

Neoplasm Metastasis Neoplasm Recurrence, Local Neoplasm, Residual Neoplasms Neoplastic Processes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leopoldina Schweinfurt, Schweinfurt, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiosurgery

Radiation

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

Primary outcomes

  1. Number of patients, in whom pain is decreased in response to treatment

    Time frame: Change in pain from baseline to 3 months post-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

Secondary outcomes

  1. Local tumor control

    Time frame: 2 years

    At the treated vertebral levels assessed with MRI

  2. Local tumor control

    Time frame: 2 years

    At the treated vertebral levels assessed with CT imaging

  3. Overall survival

    Time frame: 2 years

    Death from any cause

  4. Patient-assessed 5 dimensions of patient's quality-of-life

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

    Measured with the 5-level (no problems, slight problems, moderate problems, severe problems, and extreme problems) EuroQol 5-Dimension Questionnaire (EQ-5D) questionnaire

  5. Patient-assessed overall health status

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

    Measured with the EuroQol Visual Analog Scale from 0 ("the worst health you can imagine") to 100 (the best health you can imagine")

  6. Number of patients developing acute toxicity

    Time frame: Changes from baseline up to 6 weeks post-treatment

    Measured with NCI CTCAE v 4.0

  7. Number of patients developing late toxicity

    Time frame: Changes from >6weeks up to 2 years post-treatment

    Measured with NCI CTCAE v 4.0

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • Royal Marsden NHS Foundation Trust

Registry information

Official study title

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

Acronym: DOSIS

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
May 9, 2012
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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