Fractionated Radiosurgery for Painful Spinal Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2017-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Evaluation of the single intervention - dose-intensified SBRT

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose intensified SBRT

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.

Group Type EXPERIMENTAL

Radiosurgery

Intervention Type RADIATION

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

Interventions

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Radiosurgery

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No