Spinal Cord Compression. ICORG 05-03, V6

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00968643
First received: August 28, 2009
Last updated: August 11, 2014
Last verified: August 2014
  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
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968643

Locations
Ireland
Cork University Hospital
Cork, Ireland
Saint Luke's Radiation Oncology Network (SLRON)
Dublin, Ireland, 6
Galway University Hospital
Galway, Ireland
Whitfield Cancer Centre at Whitfield Clinic
Waterford, Ireland
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: August 11, 2014
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
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Spinal Cord Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014