Spinal Cord Compression. ICORG 05-03, V6

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

A Randomised Phase III Trial of Two Fractionation Schemes in the Treatment of Malignant Spinal Cord Compression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968643
• Other study ID #: 05-03 ICORG
• Secondary ID: ICORG-05-03EU-20
• Status: Completed
• Phase: Phase 3
• First received: August 28, 2009
• Last updated: December 30, 2014
• Start date: January 2006

Study information

• Verified date: August 2014
• Source: ICORG- All Ireland Cooperative Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Compression
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Radiation:
• radiation therapy
Given in multiple fractions or as a single fraction

Locations

Country	Name	City	State
Ireland	Cork University Hospital	Cork
Ireland	Saint Luke's Radiation Oncology Network (SLRON)	Dublin
Ireland	Galway University Hospital	Galway
Ireland	Whitfield Cancer Centre at Whitfield Clinic	Waterford

Sponsors (1)

Lead Sponsor	Collaborator
ICORG- All Ireland Cooperative Oncology Research Group

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale		5 weeks from date of randomisation	Yes
Secondary	Quality of life as assessed by the EORTC QLQ-C30 version 3 quality-of-life questionnaire		5 weeks from date of randomisation	No
Secondary	Toxicity: assessed at first follow-up, evaluated as per standard RTOG acute and long-term toxicity scale		1 week after completion of therapy	Yes
Secondary	Pain control: assessed using a Visual Analogue Scale		Until death	No
Secondary	Overall survival: the survival duration will be calculated from time of randomisation to death whatever cause		Until death	No
Secondary	Sphincter function: assessed using an 'In-House' Bladder Function Scale		Until death	No