Spinal Cord Compression. ICORG 05-03, V6

December 30, 2014 updated by: Cancer Trials Ireland

A Randomised Phase III Trial of Two Fractionation Schemes in the Treatment of Malignant Spinal Cord Compression

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cork, Ireland
        • Cork University Hospital
      • Dublin, Ireland, 6
        • Saint Luke's Radiation Oncology Network (SLRON)
      • Galway, Ireland
        • Galway University Hospital
      • Waterford, Ireland
        • Whitfield Cancer Centre at Whitfield Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm I (control)
Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).
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).
Given in multiple fractions or as a single fraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 weeks from date of randomisation

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life as assessed by the EORTC QLQ-C30 version 3 quality-of-life questionnaire
Time Frame: 5 weeks from date of randomisation
5 weeks from date of randomisation
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
1 week after completion of therapy
Pain control: assessed using a Visual Analogue Scale
Time Frame: Until death
Until death
Overall survival: the survival duration will be calculated from time of randomisation to death whatever cause
Time Frame: Until death
Until death
Sphincter function: assessed using an 'In-House' Bladder Function Scale
Time Frame: Until death
Until death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pierre Thirion, St Luke's Radiation Oncology Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

August 28, 2009

First Submitted That Met QC Criteria

August 28, 2009

First Posted (ESTIMATE)

August 31, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 30, 2014

Last Verified

August 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Unspecified Adult Solid Tumor, Protocol Specific

Clinical Trials on radiation therapy

3
Subscribe