Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression

Study Overview
=================
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.

Official Title
-----------------
SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression

Conditions
-----------------
Spinal Cord Compression, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Radiation: radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (multi-fraction radiotherapy)<br>Patients undergo 5 fractions of 20 Gy external-beam radiotherapy. | Radiation: radiation therapy<br>* Patients undergo external beam radiotherapy<br>|
| Experimental: Arm II (single-fraction radiotherapy)<br>Patients undergo 1 fraction of 8 Gy external beam radiotherapy. | Radiation: radiation therapy<br>* Patients undergo external beam radiotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient accrual per center over a 12-month period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal cord compression, unspecified adult solid tumor, protocol specific