NCT00968643

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Last Updated

December 31, 2014

Status Verified

August 1, 2014

Enrollment Period

8.3 years

First QC Date

August 28, 2009

Last Update Submit

December 30, 2014

Conditions

Spinal Cord CompressionUnspecified Adult Solid Tumor, Protocol Specific

Keywords

spinal cord compressionunspecified adult solid tumor, protocol specific

Outcome Measures

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

    5 weeks from date of randomisation

Secondary Outcomes (5)

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

    5 weeks from date of randomisation

  • Toxicity: assessed at first follow-up, evaluated as per standard RTOG acute and long-term toxicity scale

    1 week after completion of therapy

  • Pain control: assessed using a Visual Analogue Scale

    Until death

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

    Until death

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

    Until death

Study Arms (2)

Arm I (control)

ACTIVE COMPARATOR

Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).

Radiation: radiation therapy

Arm II

EXPERIMENTAL

Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).

Radiation: radiation therapy

Interventions

radiation therapyRADIATION

Given in multiple fractions or as a single fraction

Arm I (control)Arm II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Cork University Hospital

Cork, Ireland

Location

Saint Luke's Radiation Oncology Network (SLRON)

Dublin, 6, Ireland

Location

Galway University Hospital

Galway, Ireland

Location

Whitfield Cancer Centre at Whitfield Clinic

Waterford, Ireland

Location

Related Publications (1)

  • 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.

    PMID: 32157242DERIVED

MeSH Terms

Conditions

Spinal Cord Compression

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Pierre Thirion

    St Luke's Radiation Oncology Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

January 1, 2006

Primary Completion

May 1, 2014

Last Updated

December 31, 2014

Record last verified: 2014-08

Locations

IE(4)