Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT04043156
Status:
TERMINATED
Last Update Posted:
2025-01-15
First Post:
2019-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RAdiotherapy for Metastatic Spinal Cord Compression with Increased Radiation DosES
Sponsor:
University Hospital Schleswig-Holstein
Organization:
Study Overview
Official Title:
RAdiotherapy for Metastatic Spinal Cord Compression with Increased Radiation DosES
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
52 of 65 planned patients were recruited. Since during the study, survival was worse than expected, a new survival score was developed, which was more precise than the tool used for the RAMSES-01 trial. As a consequence, the trial was terminated.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAMSES-01
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: