Kypho-IORT vs. EBRT in Spinal Metastases
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|ClinicalTrials.gov Identifier: NCT02773966|
Recruitment Status : Active, not recruiting
First Posted : May 16, 2016
Last Update Posted : March 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastasis||Radiation: Kypho-IORT Radiation: EBRT||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intraoperative Radiotherapy During Kyphoplasty/Vertebroplasty (Kypho-IORT) Versus EBRT in the Treatment of Painful Vertebral Metastases - a Randomized Prospective Phase III Study -|
|Actual Study Start Date :||November 12, 2017|
|Actual Primary Completion Date :||March 19, 2020|
|Estimated Study Completion Date :||March 2022|
Experimental: Arm A: Kypho-IORT
balloon kyphoplasty/vertebroplasty + intraoperative radiotherapy
During kyphoplasty/vertebroplasty a intraoperative radiotherapy of the affected vertebrae is done with a miniature X-ray generator (INTRABEAM®, Carl Zeiss, Surgical, Oberkochen, Germany). The prescription dose will be 8 Gy in a distance of 13 mm from the isocenter of the radiation source. IORT will take about five minutes. After radiation the applicator will be removed and the operation will be finished as usual.
Active Comparator: Arm B: EBRT
external beam radiotherapy with 30 Gy during 10 days (3 Gy/day)
The external beam radiotherapy will be usually carried out as an outpatient procedure. All patients will receive a planning CT before the first irradiation. EBRT will be performed with 30 Gy, added in 3 Gy per fraction or 8 Gy single dose (only for international study centers, not permitted in Germany) on a conventional linear accelerator (LINAC).
- pain evaluation [ Time Frame: day 1 ]Evaluation of the percentage of patients with a pain reduction of VAS-3 points after Kypho-IORT vs. EBRT at day 1 (one day after Kypho-IORT; one day after the first EBRT)
- pain evaluation [ Time Frame: week 2, 6 weeks after start of treatment ]Evaluation of the percentage of patients with a pain reduction of VAS-3 at week 2 and 6 weeks after start of treatment
- local recurrence rate [ Time Frame: 6 weeks, then after 3 months, then every 6 months up to 5 years ]local recurrence diagnosed by a MRI or CT scan
- Quality of life (QoL) questionaire [ Time Frame: before start of therapy and then 6 weeks, then after 3 months, then every 6 months up to 5 years ]Assessed by European Organization for Research and Treatment (EORTC)-Quality of Life questionaires (QLQ-C30/BM22)
- Overall survival [ Time Frame: 12 Months ]Overall survival will be calculated from the date of Kypho-IORT/start of EBRT until the date of death from any cause or date of last follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773966
|Department of Radiotherapy University Hospital Mannheim|
|Mannheim, Germany, 68167|
|Principal Investigator:||Frank Giordano, MD||Universitätsmedizin Mannheim|