NCT00727584

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating metastatic spinal cord compression. PURPOSE: This randomized clinical trial is comparing two radiation therapy regimens to see how well they work in treating patients with metastatic spinal cord compression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2007

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

November 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 26, 2013

Status Verified

June 1, 2009

Enrollment Period

1.3 years

First QC Date

August 1, 2008

Last Update Submit

August 23, 2013

Conditions

Spinal Cord CompressionUnspecified Adult Solid Tumor, Protocol Specific

Keywords

spinal cord compressionunspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Patient accrual per center over a 12-month period

Secondary Outcomes (9)

  • Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline

  • Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline

  • Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment

  • Quality of life as measured by the EORTC QLQ-C30 questionnaire at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline

  • Further treatment

  • +4 more secondary outcomes

Study Arms (2)

Arm I (multi-fraction radiotherapy)

ACTIVE COMPARATOR

Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.

Radiation: radiation therapy

Arm II (single-fraction radiotherapy)

EXPERIMENTAL

Patients undergo 1 fraction of 8 Gy external beam radiotherapy.

Radiation: radiation therapy

Interventions

radiation therapyRADIATION

Patients undergo external beam radiotherapy

Arm I (multi-fraction radiotherapy)Arm II (single-fraction radiotherapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignant disease * Proven diagnosis of metastatic spinal cord compression on MRI or CT scan * Single site of compression OR multiple sites that can be treated within a single radiation treatment field * No patient for whom surgery or chemotherapy treatment is more appropriate * No multiple myeloma as primary cancer PATIENT CHARACTERISTICS: * Life expectancy \> 1 month * Not pregnant * Willing and able to complete assessment forms * Able to give informed consent PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (4)

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Cancer Research UK and University College London Cancer Trials Centre

Northwood, England, HA6 2RN, United Kingdom

Location

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

Location

Christie Hospital

Manchester, M20 6UX, United Kingdom

Location

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

  • Peter J. Hoskin, MD

    Mount Vernon Cancer Centre at Mount Vernon Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2008

First Posted

August 4, 2008

Study Start

November 1, 2007

Primary Completion

February 1, 2009

Study Completion

August 1, 2009

Last Updated

August 26, 2013

Record last verified: 2009-06

Locations

GB(4)