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Radiation Therapy in Treating Patients With Malignant Spinal Cord Compression Who Were Previously Treated With Radiation Therapy. ICORG 07-11

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974168
First Posted: September 10, 2009
Last Update Posted: December 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cancer Trials Ireland
  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 Radiation: Cumulative BED ≤ 100 Radiation: Cumulative BED ≤ 130 Gy2 Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Cancer Trials Ireland:

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

Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • Pain control via the pain visual analogue score [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ]
  • 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 ]
  • Median survival (time from the date of recruitment/treatment to death) [ Time Frame: Until death ]

Enrollment: 22
Study Start Date: October 2007
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
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
  Contacts and Locations
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, MD Saint Luke's Hospital
  More Information

Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT00974168     History of Changes
Obsolete Identifiers: NCT00624507
Other Study ID Numbers: 07-11 ICORG
ICORG-07-11
EU-20953
First Submitted: September 9, 2009
First Posted: September 10, 2009
Last Update Posted: December 21, 2016
Last Verified: December 2016

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