Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Radiation Therapy in Treating Patients With Malignant Spinal Cord Compression Who Were Previously Treated With Radiation Therapy

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	Over 18	Other	ICORG-07-11 ICORG 07-11, EU-20953, NCT00974168

Objectives

Primary

1. To determine the efficacy of a biologically effective dose-based re-irradiation strategy, in terms of the response rate (based on the mobility score using the Tomita scale where improvement in mobility or stable mobility score will be regarded as a response) in patients with malignant spinal cord compression.

Secondary

1. To determine quality of life as assessed by the EORTC QLQ-C15 PAL version 1.0 questionnaire.
2. To determine the non-spinal radiation-induced toxicity using standard RTOG criteria.
3. To determine the rate of long-term spinal toxicity and radiation-induced myelopathy using the RTOG SOMA morbidity grading system.

Entry Criteria

Disease Characteristics:

• MRI-confirmed diagnosis of malignant spinal cord compression
  • MRI of the entire spine performed
• Histologically proven malignancy
  • No primary tumors of the spine or vertebral column
• Undergone previous radiotherapy to the involved area of the spinal cord (e.g., full segment and/or ≥ 2 cm in cranio-caudal of overlap between the 2 areas treated)
  • Maximum biologically effective dose received from previous irradiation ≤ 90 Gy₂
• Deemed not suitable for neurosurgical intervention at the time of initial assessment
  • Patients deemed inoperable are eligible

Prior/Concurrent Therapy:

• See Disease Characteristics

Patient Characteristics:

• Karnofsky performance status 40-100%
• Short life expectancy
• No medical or psychiatric condition that, in the opinion of the investigator or research team, contraindicates participation in this study

Expected Enrollment

Outcomes

Response to treatment as assessed by mobility via the Tomita mobility scale
Overall response rate (stabilization and response) (stage I)

Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system
Toxicity other than spine (acute toxicity assessed at weeks 1 and 5 and late toxicity assessed at 3 months and at subsequent follow-ups) evaluated according to RTOG criteria
Pain control via the pain visual analogue score
Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire
Median survival (time from the date of recruitment/treatment to death)

Outline

Patients are divided into 2 groups according to the interval since their most recent radiotherapy to the involved area of the spinal cord.

• Group 1 (< 6 months since prior radiotherapy): Patients undergo radiotherapy for a cumulative biologically effective dose (BED) ≤ 100 Gy₂ in addition to receiving other current treatment.
• Group 2 (≥ 6 months since prior radiotherapy): Patients undergo radiotherapy for a cumulative BED ≤ 130 Gy₂ in addition to receiving other current treatment.

Mobility score is assessed and patients complete a quality-of-life assessment at baseline and at each follow-up visit starting at week 5.

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

Trial Contact Information

Trial Lead Organizations

Ireland Cooperative Oncology Research Group

Pierre Thirion, MD, Principal investigator		Ph: 353-1-406-5000

Ireland
	Dublin
	Saint Luke's Hospital
		Pierre Thirion, MD	Ph:  353-1-406-5000

Registry Information
Official Title		A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients with Malignant Spinal Cord Compression
Trial Start Date		2007-10-26
Trial Completion Date		2011-01-31 (estimated)
Registered in ClinicalTrials.gov		NCT00974168
Date Submitted to PDQ		2009-05-27
Information Last Verified		2009-09-03

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