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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Spinal Cord Compression, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale

Outcome Time Frame:

5 weeks from date of randomisation

Safety Issue:

Yes

Principal Investigator

Pierre Thirion

Investigator Role:

Principal Investigator

Investigator Affiliation:

St Luke's Radiation Oncology Network

Authority:

Ireland: Irish Medicines Board

Study ID:

CDR0000644307

NCT ID:

NCT00968643

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Spinal Cord Compression
  • Unspecified Adult Solid Tumor, Protocol Specific
  • spinal cord compression
  • unspecified adult solid tumor, protocol specific
  • Spinal Cord Compression

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