Spinal Cord Compression. ICORG 05-03, V6

Cancer Trials Ireland

Status and phase: Completed; Phase 3

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

Treatments: Radiation: radiation therapy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00968643

05-03 ICORG

ICORG-05-03

EU-20952

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 schedule is more effective in treating patients with malignant spinal cord compression.

PURPOSE: This randomized phase III trial is studying two different radiation therapy schedules to compare their side effects and how well they work in treating patients with malignant spinal cord compression.

Full description

OBJECTIVES:

Primary

To compare the response in patients with malignant spinal cord compression treated with single fraction (10 Gy) radiotherapy vs standard multiple fraction (20 Gy) radiotherapy. To compare the toxicity of these treatment regimens in these patients.

Secondary

Examine the safety, practicability, and efficacy of treatment with a single 10 Gy fraction of radiotherapy in these patients. Analyze the initial neurological status, document the response to treatment, and calculate median survival of these patients. Perform an economic impact analysis comparing the two treatment arms.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

Arm I (control): Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy). Arm II: Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).

Patients complete the EORTC QLQ-C30 quality-of-life questionnaire at baseline, at 5 weeks, and then every 3 months thereafter.

After completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months, and then every 3 months thereafter.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed malignancy, excluding the following:

  • Leukemia
  • Myeloma
  • Germ cell tumor
  • Primary tumor of the spine or vertebral column

• Diagnosis of malignant spinal cord compression confirmed by MRI of the entire spine

• Deemed inoperable or unsuitable for neurosurgical intervention at the time of initial assessment

• No single bone metastasis with controlled primary site

PATIENT CHARACTERISTICS:

• Karnofsky performance status 30-100%
• No medical or psychiatric condition that, in the opinion of the investigator or research team, would contraindicate study participation

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy to the involved area of the spinal cord such that further treatment exceeds spinal cord tolerance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Arm I (control)

Active Comparator group

Description:

Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).

Treatment:

Radiation: radiation therapy

Arm II

Experimental group

Description:

Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).

Treatment:

Radiation: radiation therapy