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RAdiotherapy for Metastatic Spinal Cord Compression With Increased Radiation dosES (RAMSES-01)

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ClinicalTrials.gov Identifier: NCT04043156
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dirk Rades, MD, University of Schleswig-Holstein

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Compression Due to Metastasis to Spine Radiation: High-precision RT Not Applicable

Detailed Description:

The aim of this single-arm study is to show that high-precision radiotherapy (RT) with 18x2.33 Gy in 3.5 weeks results in significantly better local progression free survival (LPFS) of metastatic spinal cord compression (MSCC) when compared to conventional RT with 10x3 Gy in 2 weeks. If such superiority could be shown, 18x2.33 Gy could be recommended, at least for those patients with favourable survival prognoses, since an in-field recurrence of MSCC in the irradiated part of the spine is generally very difficult to treat.

For this investigation the newly prospectively collected data will be compared with a historical cohort collected up to the time of data analysis.

The recruitment of all 65 patients (62 patients + 5% for potential drop-outs) is planned to be completed within 21 months. The follow-up period will be 12 months. This equals a total running time for the study of 33 months.

In accordance with a previous study assessing local control of MSCC, the following patient characteristics will be recorded to allow adequate comparison with the historical control group:

  • Age
  • Gender
  • Type of primary tumor (breast cancer vs. prostate cancer vs. myeloma/ lymphoma vs. lung cancer vs. other tumors)
  • Interval from tumor diagnosis to MSCC (≤15 months vs. >15 months)
  • Number of involved vertebrae (1-2 vs. ≥3)
  • Other bone metastases at the time of RT (no vs. yes)
  • Visceral metastases at the time of RT (no vs. yes)
  • Time developing motor deficits prior to RT (1-7 days vs. 8-14 days vs. >14 days)
  • Ambulatory status prior to RT (no vs. yes)
  • Eastern Cooperative Oncology Group (ECOG) performance score (0-2 vs- 3-4)
  • Indication for decompressive surgery of affected spinal areas

The patients of this study who received high-precision RT with 18x2.33 Gy for MSCC will be compared to a historical control group of patients with a favorable survival prognosis who were treated with 10x3 Gy of conventional RT. The historical control group will include data from 235 patients qualifying for the comparison with the prospectively collected data.

Data for the historical control group will be collected from an already existing anonymized database with previous study data documented in the European Union.

To be eligible for control group, patients fulfilling the same inclusion criteria and exclusion criteria as defined in the prospective study are considered. Furthermore, to be consistent with efficacy analysis of the study, patients of the historical control group must have received at least 80% of the planned RT dose.

Propensity score techniques will be applied to reduce confounding due to differences between the historical control group and the prospective trial data.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm study compared with a historical cohort.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RAdiotherapy for Metastatic Spinal Cord Compression With Increased Radiation dosES
Actual Study Start Date : August 8, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : August 31, 2022

Arm Intervention/treatment
Experimental: High-precision RT
Study Arm: 18 x 2.33 Gy of high-precision RT in 3.5 weeks.
Radiation: High-precision RT
18 x 2.33 Gy of high-precision RT in 3.5 weeks




Primary Outcome Measures :
  1. Local progression-free survival at 12 months following RT. [ Time Frame: For each patient 12 months after the end of 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.


Secondary Outcome Measures :
  1. Change in motor function/ability to walk [ Time Frame: Assessment directly and at 1, 3, 6, 9 and 12 months after RT. ]
    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.

  2. Change in quality of life [ Time Frame: Evaluation directly and at 1, 3, 6, 9 and 12 months after RT ]
    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

  3. Change in vertebral pain [ Time Frame: Evaluation directly and at 1, 3, 6, 9 and 12 months after RT ]
    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.

  4. Overall survival [ Time Frame: Evaluation directly and at 1, 3, 6, 9 and 12 months after RT ]
    Will be calculated from the last day of RT up to 12 months following RT.

  5. Local progression-free survival [ Time Frame: Additional evaluation directly and 1, 3, 6 and 9 months after RT ]
    LPFS time will be calculated from the last day of the RT.

  6. Occurence of toxicity [ Time Frame: Evaluation during RT and directly, 1, 3, 6, 9 and 12 months after RT ]
    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.

  7. Change in sensory function [ Time Frame: Evaluation during RT and directly, 1, 3, 6, 9 and 12 months after RT ]
    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.

  8. Chance in sphincter dysfunction [ Time Frame: Evaluation during RT and directly, 1, 3, 6, 9 and 12 months after RT ]
    Sphincter dysfunction will be evaluated as yes versus no.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT04043156


Contacts
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Contact: Dirk Rades, Prof. Dr. +49-451-500 ext 45401 dirk.rades@uksh.de
Contact: Liesa Dziggel, Dr. med. +49-451-500 ext 45401 liesa.dziggel@uksh.de

Locations
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Germany
Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein, Ratzeburger Allee 160, 23562 Lübeck, Germany Recruiting
Lubeck Hansestadt, Germany, 23562
Contact: Dirk Rades, Professor    +49-451-500-45400    dirk.rades@uksh.de   
Contact: Liesa Dziggel, Dr. med.    +49-451-500-45410    liesa.dziggel@uksh.de   
Sub-Investigator: Christian Staackmann         
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
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Principal Investigator: Dirk Rades, Prof. Dr. Dep. of Radiation Oncology, Univ. of Lübeck and Univ. Medical Center S-H

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Responsible Party: Prof. Dirk Rades, MD, Chair of the Department of Radiation Oncology, University of Luebeck, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT04043156     History of Changes
Other Study ID Numbers: RAMSES-01
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dirk Rades, MD, University of Schleswig-Holstein:
spinal cord compression, radiotherapy
Additional relevant MeSH terms:
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Spinal Cord Compression
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Injuries
Wounds and Injuries