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Spinal Cord Compression Re-Treat Study

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ClinicalTrials.gov Identifier: NCT00974168
Recruitment Status : Active, not recruiting
First Posted : September 10, 2009
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Brief Summary:

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 or disease Intervention/treatment Phase
Pain Radiation Toxicity Spinal Cord Compression Unspecified Adult Solid Tumor, Protocol Specific Radiation: Cumulative BED ≤ 100 Radiation: Cumulative BED ≤ 130 Gy2 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression
Study Start Date : October 2007
Actual Primary Completion Date : December 2016

Arm Intervention/treatment
Active Comparator: A
Radiation Cumulative BED ≤ 100 Gy2
Radiation: Cumulative BED ≤ 100
Radiation

Active Comparator: B
Cumulative BED ≤ 130 Gy2
Radiation: Cumulative BED ≤ 130 Gy2
Radiation




Primary Outcome Measures :
  1. Response to treatment as assessed by mobility via the Tomita mobility scale [ Time Frame: 5 weeks after completion of radiation therapy ]
  2. Overall response rate (stabilization and response) (stage I) [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ]

Secondary Outcome Measures :
  1. Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ]
  2. 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 [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ]
  3. Pain control via the pain visual analogue score [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ]
  4. Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ]
  5. Median survival (time from the date of recruitment/treatment to death) [ Time Frame: Until death ]


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974168


Locations
Ireland
Saint Luke's Radiation Oncology Network
Dublin, Ireland, 6
Galway University Hospital
Galway, Ireland
Sponsors and Collaborators
Cancer Trials Ireland
Investigators
Principal Investigator: Pierre Thirion, Dr Saint Luke's Hospital

Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT00974168     History of Changes
Obsolete Identifiers: NCT00624507
Other Study ID Numbers: CTRIAL-IE (ICORG) 07-11
ICORG 07-11
EU-20953
First Posted: September 10, 2009    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

Keywords provided by Cancer Trials Ireland:
pain
radiation toxicity
spinal cord compression
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Radiation Injuries
Spinal Cord Compression
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Injuries