Clinical trial NCT00968643: Spinal Cord Compression. ICORG 05-03, V6
Official title: A Randomised Phase III Trial of Two Fractionation Schemes in the Treatment of Malignant Spinal Cord Compression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Cord Compression
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: spinal cord compression
unspecified adult solid tumor, protocol specific
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2009-08-31
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale
timeFrame: 5 weeks from date of randomisation
Secondary outcomes:
measure: Quality of life as assessed by the EORTC QLQ-C30 version 3 quality-of-life questionnaire
timeFrame: 5 weeks from date of randomisation
measure: Toxicity: assessed at first follow-up, evaluated as per standard RTOG acute and long-term toxicity scale
timeFrame: 1 week after completion of therapy
measure: Pain control: assessed using a Visual Analogue Scale
timeFrame: Until death
measure: Overall survival: the survival duration will be calculated from time of randomisation to death whatever cause
timeFrame: Until death
measure: Sphincter function: assessed using an 'In-House' Bladder Function Scale
timeFrame: Until death
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Saint Luke's Radiation Oncology Network (SLRON)
city: Galway
country: Ireland
facility: Galway University Hospital
city: Waterford
country: Ireland
facility: Whitfield Cancer Centre at Whitfield Clinic
Study officials:
affiliation: St Luke's Radiation Oncology Network
name: Pierre Thirion
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thirion PG, Dunne MT, Kelly PJ, Flavin A, O'Sullivan JM, Hacking D, Sasiadek W, Small C, Pomeroy MM, Martin J, McArdle O, Parker I, O'Sullivan LS, Shannon AM, Clayton-Lea A, Collins CD, Stevenson MR, Alvarez-Iglesias A, Armstrong JG, Moriarty M. Non-inferiority randomised phase 3 trial comparing two radiation schedules (single vs. five fractions) in malignant spinal cord compression. Br J Cancer. 2020 Apr;122(9):1315-1323. doi: 10.1038/s41416-020-0768-z. Epub 2020 Mar 11.