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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. completion date
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


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
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