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Completed

NCT Number: NCT00968643

Spinal Cord Compression. ICORG 05-03, V6

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.

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Key information

Conditions

Spinal Cord Compression Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Unspecified Adult Solid Tumor, Protocol Specific Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cork University Hospital, Cork, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy

Radiation

Given in multiple fractions or as a single fraction

Primary outcomes

  1. 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 outcomes

  1. Quality of life as assessed by the EORTC QLQ-C30 version 3 quality-of-life questionnaire

    Time frame: 5 weeks from date of randomisation

  2. 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

  3. Pain control: assessed using a Visual Analogue Scale

    Time frame: Until death

  4. Overall survival: the survival duration will be calculated from time of randomisation to death whatever cause

    Time frame: Until death

  5. Sphincter function: assessed using an 'In-House' Bladder Function Scale

    Time frame: Until death

Sponsors and collaborators

Lead sponsor

Cancer Trials Ireland

Network

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2014
First posted
Aug 31, 2009
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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