Spinal Cord Compression. ICORG 05-03, V6
Primary Purpose
Spinal Cord Compression, Unspecified Adult Solid Tumor, Protocol Specific
Status
Completed
Phase
Phase 3
Locations
Ireland
Study Type
Interventional
Intervention
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Compression focused on measuring spinal cord compression, unspecified adult solid tumor, protocol specific
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy, excluding the following:
- Leukemia
- Myeloma
- Germ cell tumor
- Primary tumor of the spine or vertebral column
- Diagnosis of malignant spinal cord compression confirmed by MRI of the entire spine
- Deemed inoperable or unsuitable for neurosurgical intervention at the time of initial assessment
- No single bone metastasis with controlled primary site
PATIENT CHARACTERISTICS:
- Karnofsky performance status 30-100%
- No medical or psychiatric condition that, in the opinion of the investigator or research team, would contraindicate study participation
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the involved area of the spinal cord such that further treatment exceeds spinal cord tolerance
Sites / Locations
- Cork University Hospital
- Saint Luke's Radiation Oncology Network (SLRON)
- Galway University Hospital
- Whitfield Cancer Centre at Whitfield Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm I (control)
Arm II
Arm Description
Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).
Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).
Outcomes
Primary Outcome Measures
Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale
Secondary Outcome Measures
Quality of life as assessed by the EORTC QLQ-C30 version 3 quality-of-life questionnaire
Toxicity: assessed at first follow-up, evaluated as per standard RTOG acute and long-term toxicity scale
Pain control: assessed using a Visual Analogue Scale
Overall survival: the survival duration will be calculated from time of randomisation to death whatever cause
Sphincter function: assessed using an 'In-House' Bladder Function Scale
Full Information
NCT ID
NCT00968643
First Posted
August 28, 2009
Last Updated
December 30, 2014
Sponsor
Cancer Trials Ireland
1. Study Identification
Unique Protocol Identification Number
NCT00968643
Brief Title
Spinal Cord Compression. ICORG 05-03, V6
Official Title
A Randomised Phase III Trial of Two Fractionation Schemes in the Treatment of Malignant Spinal Cord Compression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Trials Ireland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy schedule is more effective in treating patients with malignant spinal cord compression.
PURPOSE: This randomized phase III trial is studying two different radiation therapy schedules to compare their side effects and how well they work in treating patients with malignant spinal cord compression.
Detailed Description
OBJECTIVES:
Primary
To compare the response in patients with malignant spinal cord compression treated with single fraction (10 Gy) radiotherapy vs standard multiple fraction (20 Gy) radiotherapy.
To compare the toxicity of these treatment regimens in these patients.
Secondary
Examine the safety, practicability, and efficacy of treatment with a single 10 Gy fraction of radiotherapy in these patients.
Analyze the initial neurological status, document the response to treatment, and calculate median survival of these patients.
Perform an economic impact analysis comparing the two treatment arms.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
Arm I (control): Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).
Arm II: Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).
Patients complete the EORTC QLQ-C30 quality-of-life questionnaire at baseline, at 5 weeks, and then every 3 months thereafter.
After completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months, and then every 3 months thereafter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Compression, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
spinal cord compression, unspecified adult solid tumor, protocol specific
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I (control)
Arm Type
Active Comparator
Arm Description
Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
Given in multiple fractions or as a single fraction
Primary Outcome Measure Information:
Title
Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale
Time Frame
5 weeks from date of randomisation
Secondary Outcome Measure Information:
Title
Quality of life as assessed by the EORTC QLQ-C30 version 3 quality-of-life questionnaire
Time Frame
5 weeks from date of randomisation
Title
Toxicity: assessed at first follow-up, evaluated as per standard RTOG acute and long-term toxicity scale
Time Frame
1 week after completion of therapy
Title
Pain control: assessed using a Visual Analogue Scale
Time Frame
Until death
Title
Overall survival: the survival duration will be calculated from time of randomisation to death whatever cause
Time Frame
Until death
Title
Sphincter function: assessed using an 'In-House' Bladder Function Scale
Time Frame
Until death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy, excluding the following:
Leukemia
Myeloma
Germ cell tumor
Primary tumor of the spine or vertebral column
Diagnosis of malignant spinal cord compression confirmed by MRI of the entire spine
Deemed inoperable or unsuitable for neurosurgical intervention at the time of initial assessment
No single bone metastasis with controlled primary site
PATIENT CHARACTERISTICS:
Karnofsky performance status 30-100%
No medical or psychiatric condition that, in the opinion of the investigator or research team, would contraindicate study participation
PRIOR CONCURRENT THERAPY:
No prior radiotherapy to the involved area of the spinal cord such that further treatment exceeds spinal cord tolerance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Thirion
Organizational Affiliation
St Luke's Radiation Oncology Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Saint Luke's Radiation Oncology Network (SLRON)
City
Dublin
ZIP/Postal Code
6
Country
Ireland
Facility Name
Galway University Hospital
City
Galway
Country
Ireland
Facility Name
Whitfield Cancer Centre at Whitfield Clinic
City
Waterford
Country
Ireland
12. IPD Sharing Statement
Citations:
PubMed Identifier
32157242
Citation
Thirion PG, Dunne MT, Kelly PJ, Flavin A, O'Sullivan JM, Hacking D, Sasiadek W, Small C, Pomeroy MM, Martin J, McArdle O, Parker I, O'Sullivan LS, Shannon AM, Clayton-Lea A, Collins CD, Stevenson MR, Alvarez-Iglesias A, Armstrong JG, Moriarty M. Non-inferiority randomised phase 3 trial comparing two radiation schedules (single vs. five fractions) in malignant spinal cord compression. Br J Cancer. 2020 Apr;122(9):1315-1323. doi: 10.1038/s41416-020-0768-z. Epub 2020 Mar 11.
Results Reference
derived
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Spinal Cord Compression. ICORG 05-03, V6
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