Overview

This trial is active, not recruiting.

Conditions neoplasm metastasis, neoplastic processes, neoplasm recurrence, local, neoplasm, residual, pain
Treatment radiosurgery
Phase phase 2
Sponsor Wuerzburg University Hospital
Collaborator Royal Marsden NHS Foundation Trust
Start date April 2012
End date January 2015
Trial size 60 participants
Trial identifier NCT01594892, DOSIS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
radiosurgery
Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery
(Experimental)
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
radiosurgery
Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery

Primary Outcomes

Measure
Pain response
time frame: 3 months

Secondary Outcomes

Measure
Local tumor control
time frame: 2 years
Overall survival
time frame: 2 years
Cancer specific mortality
time frame: 2 years
Quality of life
time frame: 3 months
Toxicity
time frame: 2 years

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)
Principal investigator Matthias Guckenberger, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Wuerzburg University Hospital.