Spinal Cord Compression Due to Metastasis to Spine Clinical Trial
— RAMSES-01Official title:
RAdiotherapy for Metastatic Spinal Cord Compression With Increased Radiation dosES
This clinical study aims to investigate whether high-precision radiotherapy, as supposed, leads to a better control of the irradiated spinal cord metastases when compared to conventional radiotherapy. This means that a progression or recurrence of motor deficits (weakness) of the legs following radiotherapy can be avoided more effectively. Furthermore, the high-precision radiotherapy will be compared to the conventional radiotherapy with respect to pain relief, motor function/ability to walk, quality of life, side effects and survival.
Status | Recruiting |
Enrollment | 65 |
Est. completion date | December 31, 2022 |
Est. primary completion date | August 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Motor deficits of the lower extremities resulting from MSCC, which have persisted for no longer than 30 days 2. Confirmation of diagnosis by MR-imaging (computed tomography [CT] allowed) 3. Age 18 years or older 4. Written informed consent 5. Favorable survival prognosis (defined as 36-45 points on the survival score) 6. Capacity of the patient to contract Exclusion Criteria: 1. Previous RT or surgery of the spinal areas affected by MSCC 2. Symptomatic brain tumor or symptomatic brain metastases 3. Metastases of the cervical spine only 4. Other severe neurological disorders 5. Pregnancy, Lactation 6. Clear indication for spinal surgery |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein, Ratzeburger Allee 160, 23562 Lübeck, Germany | Lubeck Hansestadt |
Lead Sponsor | Collaborator |
---|---|
University Hospital Schleswig-Holstein |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local progression-free survival at 12 months following RT. | LPFS time will be calculated from the last day of the RT. The evaluation will be performed in those patients, who are available for assessement of the Primary endpoint and have received at least 80% of the planned RT dose. | For each patient 12 months after the end of RT. | |
Secondary | Change in motor function/ability to walk | Change in motor function is defined as improvement or deterioration by at least one point. 0=normal strength; 1=ambulatory without aid; 2 ambulatory with aid; 3=not ambulatory;4=complete paraplegia. Motor function will additionally be evaluated using additionally the American Spinal Injury Association (ASIA) classification resulting in total points of 0 to 14. | Assessment directly and at 1, 3, 6, 9 and 12 months after RT. | |
Secondary | Change in quality of life | Quality of life (QoL) will be assessed using the distress thermometer. Patients can rate their impairment in QoL between 0 and 10 (no to maximum impairment). The data will be compared to the data documented prior to RT | Evaluation directly and at 1, 3, 6, 9 and 12 months after RT | |
Secondary | Change in vertebral pain | Vertebral pain will be evaluated with a numeric rating scale (self-assessment by patients ) from 0=no pain to 10=worst pain. Improvement by 2 points is rated partial response, 0 points complete response. The data will be compared to the data documented prior to RT. The intake of analgesics will be included. | Evaluation directly and at 1, 3, 6, 9 and 12 months after RT | |
Secondary | Overall survival | Will be calculated from the last day of RT up to 12 months following RT. | Evaluation directly and at 1, 3, 6, 9 and 12 months after RT | |
Secondary | Local progression-free survival | LPFS time will be calculated from the last day of the RT. | Additional evaluation directly and 1, 3, 6 and 9 months after RT | |
Secondary | Occurence of toxicity | Toxicity will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) 4.3. If radiation myelopathy is suspected, spinal Magnetic Resonance (MR)-Imaging will be performed. The data will be compared to the data documented prior to RT. | Evaluation during RT and directly, 1, 3, 6, 9 and 12 months after RT | |
Secondary | Change in sensory function | Sensory function will be evaluated using the following scale, modified in accordance to the ASIA classification, 0=absent, 1=impaired, 2=normal, 9=cannot be assessed. | Evaluation during RT and directly, 1, 3, 6, 9 and 12 months after RT | |
Secondary | Chance in sphincter dysfunction | Sphincter dysfunction will be evaluated as yes versus no. | Evaluation during RT and directly, 1, 3, 6, 9 and 12 months after RT |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03070431 -
High-precision Radiotherapy of Motor Deficits Due to Metastatic Spinal Cord Compression
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N/A |