Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression

Cancer Research UK (CRUK)

Status: Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Spinal Cord Compression

Treatments: Radiation: radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00727584

ISRCTN97555949

CRUK-SCORAD

CRUK-UCL-BRD-07-010

CDR0000599886

EU-20863

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

100 participants in 2 patient groups

Arm I (multi-fraction radiotherapy)

Active Comparator group

Description:

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

Treatment:

Radiation: radiation therapy

Arm II (single-fraction radiotherapy)

Experimental group

Description:

Patients undergo 1 fraction of 8 Gy external beam radiotherapy.

Treatment:

Radiation: radiation therapy