Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression

Not Applicable

Completed

• Conditions: Spinal Cord Compression; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Radiation: radiation therapy

• Registration Number: NCT00727584
• Lead Sponsor: Cancer Research UK

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.

Detailed Description

OBJECTIVES:

* To examine whether a phase III randomized study comparing a single-fraction of radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and to patients with metastatic spinal cord compression.

* To determine the feasibility of conducting this study in the United Kingdom.

OUTLINE: This is a multicenter study. Patients are stratified by treatment center and known prognostic factors (ambulatory status at diagnosis, primary tumor type, and extent of disease \[spinal metastases only vs spinal and non-bony metastases\]). Patients are randomized to 1 of 2 treatment arms.

* Arm I (multi-fraction radiotherapy): Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.

* Arm II (single-fraction radiotherapy): Patients undergo 1 fraction of 8 Gy external beam radiotherapy.

Patients undergo assessment of ambulatory status, quality of life, bladder and bowel function, and acute toxicity via self-reported questionnaires and telephone follow-ups at baseline and weeks 1, 4, 8, and 12.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-08-01
• Study First Submitted QC: 2008-08-01
• Study First Posted: 2008-08-04
• Primary Completion: 2009-02
• Status Verified: 2009-06
• Study Completion: 2009-08
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm I (multi-fraction radiotherapy)	radiation therapy	Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
Arm II (single-fraction radiotherapy)	radiation therapy	Patients undergo 1 fraction of 8 Gy external beam radiotherapy.

Primary Outcome Measures

Name	Time	Method
Patient accrual per center over a 12-month period

Secondary Outcome Measures

Name	Time	Method
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
Overall survival at 3, 6, and 12 months
Total number of days spent in hospital
Preferred place of care
Number of patients eligible but not randomized and reasons for non-randomization

Trial Locations

Locations (4)

Christie Hospital; 🇬🇧 Manchester, United Kingdom

Bristol Haematology and Oncology Centre; 🇬🇧 Bristol, England, United Kingdom

Cancer Research UK and University College London Cancer Trials Centre; 🇬🇧 Northwood, England, United Kingdom

Glan Clwyd Hospital; 🇬🇧 Rhyl, Denbighshire, Wales, United Kingdom