Radiation Therapy in Treating Patients With Malignant Spinal Cord Compression
This study is currently recruiting participants.
Verified October 2012 by ICORG- All Ireland Cooperative Oncology Research Group
Sponsor:
ICORG- All Ireland Cooperative Oncology Research Group
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00968643
First received: August 28, 2009
Last updated: October 17, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Compression Unspecified Adult Solid Tumor, Protocol Specific |
Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomised Phase III Trial of Two Fractionation Schemes in the Treatment of Malignant Spinal Cord Compression |
Resource links provided by NLM:
Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:
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 [ Time Frame: 5 weeks from date of randomisation ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Quality of life as assessed by the EORTC QLQ-C30 version 3 quality-of-life questionnaire [ Time Frame: 5 weeks from date of randomisation ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- Pain control: assessed using a Visual Analogue Scale [ Time Frame: Until death ] [ Designated as safety issue: No ]
- Overall survival: the survival duration will be calculated from time of randomisation to death whatever cause [ Time Frame: Until death ] [ Designated as safety issue: No ]
- Sphincter function: assessed using an 'In-House' Bladder Function Scale [ Time Frame: Until death ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 126 |
| Study Start Date: | January 2006 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I (control)
Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).
|
Radiation: radiation therapy
Given in multiple fractions or as a single fraction
|
|
Experimental: Arm II
Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).
|
Radiation: radiation therapy
Given in multiple fractions or as a single fraction
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968643
Locations
| Ireland | |
| Cork University Hospital | Recruiting |
| Cork, Ireland | |
| Contact: Contact Person 353-21-492-0051 | |
| Saint Luke's Radiation Oncology Network (SLRON) | Recruiting |
| Dublin, Ireland, 6 | |
| Contact: Contact Person 353-1-406-5000 | |
| Galway University Hospital | Recruiting |
| Galway, Ireland | |
| Contact: Contact Person 353-91-542-615 | |
| Whitfield Cancer Centre at Whitfield Clinic | Recruiting |
| Waterford, Ireland | |
| Contact: Contact Person 353-51-337-438 | |
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
Investigators
| Principal Investigator: | Pierre Thirion | St Luke's Radiation Oncology Network |
More Information
Additional Information:
No publications provided
| Responsible Party: | ICORG- All Ireland Cooperative Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT00968643 History of Changes |
| Other Study ID Numbers: | CDR0000644307, ICORG-05-03, EU-20952 |
| Study First Received: | August 28, 2009 |
| Last Updated: | October 17, 2012 |
| Health Authority: | Ireland: Irish Medicines Board |
Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
|
spinal cord compression unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Spinal Cord Compression Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Spinal Cord Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013