Radiation Therapy in Treating Patients With Malignant Spinal Cord Compression Who Were Previously Treated With Radiation Therapy - Full Text View

Sponsor:	All Ireland Cooperative Oncology Research Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00974168

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may be effective in treating malignant spinal cord compression in patients who have received previous radiation therapy to the spine.

PURPOSE: This phase II trial is studying radiation therapy in treating patients with malignant spinal cord compression.

Condition	Intervention	Phase
Pain Radiation Toxicity Spinal Cord Compression Unspecified Adult Solid Tumor, Protocol Specific	Procedure: quality-of-life assessment Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response to treatment as assessed by mobility via the Tomita mobility scale [ Designated as safety issue: No ]
Overall response rate (stabilization and response) (stage I) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system [ Designated as safety issue: Yes ]
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 [ Designated as safety issue: Yes ]
Pain control via the pain visual analogue score [ Designated as safety issue: No ]
Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire [ Designated as safety issue: No ]
Median survival (time from the date of recruitment/treatment to death) [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2007
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

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

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

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 Gy_2 in addition to receiving other current treatment.
Group 2 (≥ 6 months since prior radiotherapy): Patients undergo radiotherapy for a cumulative BED ≤ 130 Gy_2 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 Gy_2
Deemed not suitable for neurosurgical intervention at the time of initial assessment
- Patients deemed inoperable are eligible

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

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974168

Locations

Ireland
Saint Luke's Hospital	Recruiting
Dublin, Ireland, 6
Contact: Pierre Thirion, MD 353-1-406-5000

Sponsors and Collaborators

All Ireland Cooperative Oncology Research Group

Investigators

Principal Investigator:

Pierre Thirion, MD

Saint Luke's Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000644385, ICORG-07-11, EU-20953
Study First Received:	September 9, 2009
Last Updated:	October 7, 2009
ClinicalTrials.gov Identifier:	NCT00974168 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

pain
radiation toxicity
spinal cord compression
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Spinal Cord Injuries
Spinal Cord Diseases
Spinal Cord Compression
Nervous System Diseases

Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

ClinicalTrials.gov processed this record on February 04, 2010