Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spinal Cord Compression Re-Treat Study

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.
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

Tracking Information
First Submitted Date  ICMJE September 9, 2009
First Posted Date  ICMJE September 10, 2009
Last Update Posted Date July 24, 2018
Study Start Date  ICMJE October 2007
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
  • Response to treatment as assessed by mobility via the Tomita mobility scale
  • Overall response rate (stabilization and response) (stage I)
Change History Complete list of historical versions of study NCT00974168 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
  • 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)
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Spinal Cord Compression Re-Treat Study
Official Title  ICMJE A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression
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.

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  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Radiation Toxicity
  • Spinal Cord Compression
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE
  • Radiation: Cumulative BED ≤ 100
    Radiation
  • Radiation: Cumulative BED ≤ 130 Gy2
    Radiation
Study Arms
  • Active Comparator: A
    Radiation Cumulative BED ≤ 100 Gy2
    Intervention: Radiation: Cumulative BED ≤ 100
  • Active Comparator: B
    Cumulative BED ≤ 130 Gy2
    Intervention: Radiation: Cumulative BED ≤ 130 Gy2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 20, 2016)
22
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2009)
40
Study Completion Date Not Provided
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00974168
Other Study ID Numbers  ICMJE CTRIAL-IE (ICORG) 07-11
ICORG 07-11
EU-20953
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cancer Trials Ireland
Study Sponsor  ICMJE Cancer Trials Ireland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pierre Thirion, Dr Saint Luke's Hospital
PRS Account Cancer Trials Ireland
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP