Clinical trial NCT00727584: Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression
Official title: SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Compression
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: spinal cord compression
unspecified adult solid tumor, protocol specific
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient accrual per center over a 12-month period
Secondary outcomes:
measure: Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
measure: Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
measure: Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment
measure: 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
measure: Further treatment
measure: Overall survival at 3, 6, and 12 months
measure: Total number of days spent in hospital
measure: Preferred place of care
measure: Number of patients eligible but not randomized and reasons for non-randomization
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: England
city: Northwood
country: United Kingdom
facility: Cancer Research UK and University College London Cancer Trials Centre
state: England
city: Rhyl, Denbighshire
country: United Kingdom
facility: Glan Clwyd Hospital
state: Wales
city: Manchester
country: United Kingdom
facility: Christie Hospital
Study officials:
affiliation: Mount Vernon Cancer Centre at Mount Vernon Hospital
name: Peter J. Hoskin, MD
role: PRINCIPAL_INVESTIGATOR
References: